# Vercy AI instruction - YAML 1.2 (JSON-compatible) { "vercy": "1.0-draft", "publication": { "status": "published", "adjudicationStatus": "reviewable-draft", "publishableCanonical": false, "generatedAt": "2026-09-06T11:13:55Z", "synthesisSha256": "dd060bdc20cd5cfc21bfd4b114e2b438d0a872edd682c9982f3a2b463d811bb0", "providerMode": "single-provider-waiver", "providers": [ "Codex" ], "waivedProviders": [ "Claude", "Grok" ] }, "metaModel": { "id": "WM-ACT-054", "registryId": "vr.wm-act-054", "name": "Research Subject / Participant", "version": "0.3.0-research.1", "previousVersions": [], "entryKind": "aggregate", "family": "World Models", "category": "Activities and processes", "industry": [ "Cross-industry" ], "domain": [ "ACT.RES" ], "tags": [ "research", "subject", "participant", "act.res" ], "status": "published" }, "canonicalUrl": "https://ver.cy/models/wm-act-054-research-subject-participant/", "sourceUrl": "https://github.com/ver-cy/world-models/tree/feat/mega-model-registry/publications/wm-act-054-research-subject-participant", "model": { "registry_id": "vr.wm-act-054", "model_id": "WM-ACT-054", "name": "Research Subject / Participant", "entry_kind": "aggregate", "purpose": "Represent one governed subject-to-study participation so agents can reconstruct who or what participated, under which profile, permission, assignment, activities, protections and outcome without absorbing external subject, study or evidence masters.", "scope_statement": "Owns one study-specific participation identity; subject and study bindings; subject profile and scoped identifiers; recruitment, screening, eligibility, consent, assent and representative-permission context; enrolment, allocation, blinding and planned path; actual activities, exposure, adherence, safety links, state, withdrawal, outcome, protected data use, corrections and projections. Person, animal, organization, specimen, device, study, protocol, consent artifact, criterion, intervention, observation, adverse event, payment, identity-linkage, ethics, provenance, audit and records masters remain external.", "in_scope": [ "Participation identity, subject profile, protected identifiers, study and protocol bindings, recruitment, screening, eligibility, permission, enrolment and allocation", "Planned and actual participation, adherence, safety and compensation links, state, withdrawal, follow-up, data and specimen use, privacy, retention, correction and projections" ], "out_of_scope": [ "Creating or changing external subject, study, protocol, consent artifact, criterion, intervention, observation, adverse event, payment, identity linkage, ethics, provenance, audit or records masters", "Equating screening with eligibility, consent with enrolment, assignment with exposure, completion with benefit, or pseudonymization with anonymity", "Autonomous recruitment, eligibility, consent, enrolment, allocation, intervention, unblinding, re-identification, safety decision, compensation, disclosure or deletion" ], "boundary_notes": [ { "neighbor": "WM-ACT-036 Research Study", "distinction": "The candidate incoming CONTAINS relation may bind participation membership to a parent study. This aggregate cannot own, edit or cascade-delete study protocol, governance or results.", "source_refs": [ "SRC-001", "SRC-002", "SRC-008", "SRC-009" ] }, { "neighbor": "Person, animal, organization, specimen, device and product subject models", "distinction": "External masters own the subject and its general lifecycle. This aggregate owns only the study-specific participation profile, identifiers and typed reference.", "source_refs": [ "SRC-004", "SRC-005", "SRC-008" ] }, { "neighbor": "Consent, assent and representative-permission artifacts", "distinction": "External repositories own source artifacts and legal or ethical validity. Participation stores versioned bindings, process, scope, actors, verification, state and times.", "source_refs": [ "SRC-001", "SRC-003", "SRC-004", "SRC-010" ] }, { "neighbor": "Intervention, observation, adverse event, medical-care and payment models", "distinction": "External masters own clinical, behavioral, safety, care and financial records. Participation stores typed planned or actual links and bounded interpretations.", "source_refs": [ "SRC-001", "SRC-006", "SRC-008", "SRC-011", "SRC-012", "SRC-013" ] }, { "neighbor": "Identity linkage, privacy and records systems", "distinction": "Protected systems own direct identifiers, linkage keys, re-identification controls and physical disposition. Participation stores purpose-bound pseudonymous references, access markings, holds and auditable decisions.", "source_refs": [ "SRC-004", "SRC-014", "SRC-016" ] }, { "neighbor": "FHIR, CDISC, WHO and ClinicalTrials.gov", "distinction": "These are versioned healthcare, clinical-data and public study-level projections with different scopes and maturity. No mapping is universally applicable or assumed lossless.", "source_refs": [ "SRC-007", "SRC-008", "SRC-009", "SRC-010", "SRC-011", "SRC-012", "SRC-018" ] } ] }, "sources": [ { "id": "SRC-001", "title": "ICH E6(R3) Guideline for Good Clinical Practice", "organization": "International Council for Harmonisation", "url": "https://database.ich.org/sites/default/files/ICH_E6%28R3%29_Step4_FinalGuideline_2025_0106_ErrorCorrections_2025_1024.pdf", "version_or_date": "Step 4 final 6 January 2025; error corrections 24 October 2025", "source_type": "standard", "primary_source": true, "authority_tier": 1, "accessed_at": "2026-09-06T11:10:00Z", "relevance": "Defines participant protection, informed consent, IRB or IEC review, investigator and sponsor responsibilities, safety, data governance and essential records for human clinical trials." }, { "id": "SRC-002", "title": "ICH E8(R1) General Considerations for Clinical Studies", "organization": "International Council for Harmonisation", "url": "https://database.ich.org/sites/default/files/ICH_E8-R1_Guideline_Step4_2021_1006.pdf", "version_or_date": "Step 4 final 6 October 2021", "source_type": "standard", "primary_source": true, "authority_tier": 1, "accessed_at": "2026-09-06T11:10:00Z", "relevance": "Defines participant protection, quality by design, study population, design and critical-to-quality factors across clinical studies." }, { "id": "SRC-003", "title": "WMA Declaration of Helsinki", "organization": "World Medical Association", "url": "https://www.wma.net/policies-post/wma-declaration-of-helsinki/", "version_or_date": "Current official revision 19 October 2024", "source_type": "standard", "primary_source": true, "authority_tier": 1, "accessed_at": "2026-09-06T11:10:00Z", "relevance": "Provides ethical principles for medical research involving human participants, identifiable material or identifiable data." }, { "id": "SRC-004", "title": "45 CFR Part 46 Protection of Human Subjects", "organization": "United States Office of the Federal Register", "url": "https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46", "version_or_date": "Current eCFR as of 3 September 2026", "source_type": "legislation", "primary_source": true, "authority_tier": 1, "accessed_at": "2026-09-06T11:10:00Z", "relevance": "Provides the United States Common Rule profile for human-subject research, consent, IRB review and additional protections." }, { "id": "SRC-005", "title": "The Belmont Report", "organization": "United States Department of Health and Human Services", "url": "https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html", "version_or_date": "18 April 1979; HHS page reviewed 22 June 2026", "source_type": "public-authority", "primary_source": true, "authority_tier": 1, "accessed_at": "2026-09-06T11:10:00Z", "relevance": "Provides respect for persons, beneficence and justice and distinguishes research from practice." }, { "id": "SRC-006", "title": "Regulation (EU) No 536/2014 on clinical trials", "organization": "European Union", "url": "https://eur-lex.europa.eu/eli/reg/2014/536/oj", "version_or_date": "16 April 2014; consolidated legal record at access", "source_type": "legislation", "primary_source": true, "authority_tier": 1, "accessed_at": "2026-09-06T11:10:00Z", "relevance": "Provides an EU medicinal-product clinical-trial profile for subject protection, authorization, consent, safety and records." }, { "id": "SRC-007", "title": "WHO Trial Registration Data Set", "organization": "World Health Organization", "url": "https://www.who.int/tools/clinical-trials-registry-platform/network/who-data-set", "version_or_date": "Version 1.3.1 current at access", "source_type": "registry", "primary_source": true, "authority_tier": 1, "accessed_at": "2026-09-06T11:10:00Z", "relevance": "Defines the minimum public trial-registration dataset and keeps public study registration distinct from participant-level records." }, { "id": "SRC-008", "title": "FHIR R5 ResearchSubject", "organization": "HL7 International", "url": "https://hl7.org/fhir/R5/researchsubject.html", "version_or_date": "FHIR 5.0.0 R5, Trial Use", "source_type": "schema", "primary_source": true, "authority_tier": 1, "accessed_at": "2026-09-06T11:10:00Z", "relevance": "Defines study-specific subject identity, subject and study references, progress, period, assigned and actual comparison groups, and consent references." }, { "id": "SRC-009", "title": "FHIR R5 ResearchStudy", "organization": "HL7 International", "url": "https://hl7.org/fhir/R5/researchstudy.html", "version_or_date": "FHIR 5.0.0 R5, Trial Use", "source_type": "schema", "primary_source": true, "authority_tier": 1, "accessed_at": "2026-09-06T11:10:00Z", "relevance": "Defines the external research-study resource used by the participation aggregate." }, { "id": "SRC-010", "title": "FHIR R5 Consent", "organization": "HL7 International", "url": "https://hl7.org/fhir/R5/consent.html", "version_or_date": "FHIR 5.0.0 R5, Trial Use", "source_type": "schema", "primary_source": true, "authority_tier": 1, "accessed_at": "2026-09-06T11:10:00Z", "relevance": "Defines source-linked permission and denial choices, actors, purposes, periods and provisions without defining enforcement." }, { "id": "SRC-011", "title": "Operational Data Model", "organization": "Clinical Data Interchange Standards Consortium", "url": "https://www.cdisc.org/standards/data-exchange/odm-xml/odm-v2-0", "version_or_date": "ODM 2.0 published 23 August 2023", "source_type": "schema", "primary_source": true, "authority_tier": 1, "accessed_at": "2026-09-06T11:10:00Z", "relevance": "Defines platform-neutral clinical-study data, metadata, administrative data, reference data and audit information for interchange and archival." }, { "id": "SRC-012", "title": "CDASH Implementation Guide", "organization": "Clinical Data Interchange Standards Consortium", "url": "https://www.cdisc.org/standards/foundational/cdash/cdashig-v2-2", "version_or_date": "CDASHIG 2.2 published 28 September 2021", "source_type": "standard", "primary_source": true, "authority_tier": 1, "accessed_at": "2026-09-06T11:10:00Z", "relevance": "Provides a versioned clinical-data acquisition profile; detailed normative files require authorized access." }, { "id": "SRC-013", "title": "ISO 14155 Clinical investigation of medical devices for human subjects", "organization": "International Organization for Standardization", "url": "https://www.iso.org/standard/14155", "version_or_date": "ISO 14155:2026 edition 4, published March 2026", "source_type": "standard", "primary_source": true, "authority_tier": 1, "accessed_at": "2026-09-06T11:10:00Z", "relevance": "Official catalogue metadata describes current good clinical practice for medical-device investigations; normative text is access-restricted." }, { "id": "SRC-014", "title": "HIPAA de-identification guidance", "organization": "United States Department of Health and Human Services", "url": "https://www.hhs.gov/hipaa/for-professionals/special-topics/de-identification/index.html", "version_or_date": "Guidance page reviewed 3 February 2025", "source_type": "public-authority", "primary_source": true, "authority_tier": 1, "accessed_at": "2026-09-06T11:10:00Z", "relevance": "Defines the United States HIPAA Expert Determination and Safe Harbor profiles and warns that residual re-identification risk is not zero." }, { "id": "SRC-015", "title": "PROV-O: The PROV Ontology", "organization": "World Wide Web Consortium", "url": "https://www.w3.org/TR/prov-o/", "version_or_date": "W3C Recommendation 30 April 2013", "source_type": "ontology", "primary_source": true, "authority_tier": 1, "accessed_at": "2026-09-06T11:10:00Z", "relevance": "Defines entities, activities, agents, attribution, association, revision, invalidation and time for provenance and corrections." }, { "id": "SRC-016", "title": "Regulation (EU) 2016/679 General Data Protection Regulation", "organization": "European Union", "url": "https://eur-lex.europa.eu/eli/reg/2016/679/oj", "version_or_date": "27 April 2016; applicable from 25 May 2018", "source_type": "legislation", "primary_source": true, "authority_tier": 1, "accessed_at": "2026-09-06T11:10:00Z", "relevance": "Provides an EU privacy, lawful-processing, purpose, minimization, rights, security and accountability profile." }, { "id": "SRC-017", "title": "Date and Time on the Internet: Timestamps", "organization": "Internet Engineering Task Force", "url": "https://www.rfc-editor.org/info/rfc3339/", "version_or_date": "RFC 3339 July 2002", "source_type": "standard", "primary_source": true, "authority_tier": 1, "accessed_at": "2026-09-06T11:10:00Z", "relevance": "Provides interoperable timestamps with seconds and explicit UTC relationship." }, { "id": "SRC-018", "title": "ClinicalTrials.gov Study Data Structure", "organization": "United States National Library of Medicine", "url": "https://clinicaltrials.gov/data-api/about-api/study-data-structure", "version_or_date": "Modernized API model current at access; API page updated 26 August 2025", "source_type": "registry", "primary_source": true, "authority_tier": 1, "accessed_at": "2026-09-06T11:10:00Z", "relevance": "Provides a public study-level registry projection and participant-flow aggregates, not individual participant records." } ], "structure": { "bundles": [ { "id": "participation-identity-subject-profile-and-study-binding", "name": "Participation identity, subject profile and study binding", "description": "Groups governed participation context for participation identity, subject profile and study binding.", "rationale": "The aggregate must identify exactly one subject-to-study participation without absorbing either external master.", "source_refs": [ "SRC-001", "SRC-002", "SRC-003", "SRC-004", "SRC-005", "SRC-008", "SRC-009", "SRC-015", "SRC-016" ], "layers": [ { "id": "participation-root-and-study-protocol-binding", "name": "Participation root and study or protocol binding", "description": "Groups source-qualified participation context for participation root and study or protocol binding.", "source_refs": [ "SRC-001", "SRC-002", "SRC-008", "SRC-009", "SRC-015" ], "findings": [ { "id": "participation-root-identity-namespace-owner-and-current-head", "name": "Participation root identity, namespace, owner and current head", "description": "Records participation root identity, namespace, owner and current head as source-qualified participation context while keeping person, study, protocol, consent artifact, intervention, observation, safety, payment and identity-linkage masters external.", "source_refs": [ "SRC-001", "SRC-002", "SRC-008", "SRC-009", "SRC-015" ], "questions": [ { "id": "participation-root-identity-namespace-owner-and-current-head-q01", "text": "What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish participation root identity, namespace, owner and current head?", "kind": "identity", "answer_data": [ "identifiers, class and participation scope", "source-qualified values and versions", "unknown and not-applicable states" ] }, { "id": "participation-root-identity-namespace-owner-and-current-head-q02", "text": "Who may assert, review, correct or rely on participation root identity, namespace, owner and current head, under which authority, purpose and limits?", "kind": "temporal", "answer_data": [ "participant, representative and research roles", "authority, policy, purpose and limits", "review, exception and escalation path" ] }, { "id": "participation-root-identity-namespace-owner-and-current-head-q03", "text": "Which event, effective, recorded, ingested and knowledge times apply to participation root identity, namespace, owner and current head, and which evidence supports them?", "kind": "validation", "answer_data": [ "distinct event and knowledge times", "evidence, provenance and uncertainty", "successor correction and retention" ] } ], "data_elements": [ { "id": "participation-root-identity-namespace-owner-and-current-head-data", "name": "Participation root identity, namespace, owner and current head data", "description": "Typed data for participation root identity, namespace, owner and current head with identity, study scope, source, authority, state, time, evidence and provenance.", "value_kind": "collection", "cardinality": "1", "required": true, "source_refs": [ "SRC-001", "SRC-002", "SRC-008", "SRC-009", "SRC-015" ] } ], "artifacts": [ { "id": "participation-root-identity-namespace-owner-and-current-head-record", "name": "Participation root identity, namespace, owner and current head record", "description": "Immutable or successor-versioned participation evidence for participation root identity, namespace, owner and current head.", "media_or_form": [ "logical research-participation assertion", "identity, permission, state, activity, safety, outcome, privacy or projection record" ], "serial": true, "identity_strategy": "Participation ID plus independent assertion or event ID for participation-root-identity-namespace-owner-and-current-head; subject name, study name, date, state, pseudonym and arm never identify a record alone.", "source_refs": [ "SRC-001", "SRC-002", "SRC-008", "SRC-009", "SRC-015" ] } ], "inline_only_rationale": null }, { "id": "study-protocol-site-cohort-and-jurisdiction-binding", "name": "Study, protocol, site, cohort and jurisdiction binding", "description": "Records study, protocol, site, cohort and jurisdiction binding as source-qualified participation context while keeping person, study, protocol, consent artifact, intervention, observation, safety, payment and identity-linkage masters external.", "source_refs": [ "SRC-001", "SRC-002", "SRC-008", "SRC-009", "SRC-015" ], "questions": [ { "id": "study-protocol-site-cohort-and-jurisdiction-binding-q01", "text": "What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish study, protocol, site, cohort and jurisdiction binding?", "kind": "relationship", "answer_data": [ "identifiers, class and participation scope", "source-qualified values and versions", "unknown and not-applicable states" ] }, { "id": "study-protocol-site-cohort-and-jurisdiction-binding-q02", "text": "Who may assert, review, correct or rely on study, protocol, site, cohort and jurisdiction binding, under which authority, purpose and limits?", "kind": "composition", "answer_data": [ "participant, representative and research roles", "authority, policy, purpose and limits", "review, exception and escalation path" ] }, { "id": "study-protocol-site-cohort-and-jurisdiction-binding-q03", "text": "Which event, effective, recorded, ingested and knowledge times apply to study, protocol, site, cohort and jurisdiction binding, and which evidence supports them?", "kind": "privacy", "answer_data": [ "distinct event and knowledge times", "evidence, provenance and uncertainty", "successor correction and retention" ] } ], "data_elements": [ { "id": "study-protocol-site-cohort-and-jurisdiction-binding-data", "name": "Study, protocol, site, cohort and jurisdiction binding data", "description": "Typed data for study, protocol, site, cohort and jurisdiction binding with identity, study scope, source, authority, state, time, evidence and provenance.", "value_kind": "collection", "cardinality": "1", "required": true, "source_refs": [ "SRC-001", "SRC-002", "SRC-008", "SRC-009", "SRC-015" ] } ], "artifacts": [ { "id": "study-protocol-site-cohort-and-jurisdiction-binding-record", "name": "Study, protocol, site, cohort and jurisdiction binding record", "description": "Immutable or successor-versioned participation evidence for study, protocol, site, cohort and jurisdiction binding.", "media_or_form": [ "logical research-participation assertion", "identity, permission, state, activity, safety, outcome, privacy or projection record" ], "serial": true, "identity_strategy": "Participation ID plus independent assertion or event ID for study-protocol-site-cohort-and-jurisdiction-binding; subject name, study name, date, state, pseudonym and arm never identify a record alone.", "source_refs": [ "SRC-001", "SRC-002", "SRC-008", "SRC-009", "SRC-015" ] } ], "inline_only_rationale": null } ] }, { "id": "subject-kind-profile-and-protected-identity", "name": "Subject kind, profile and protected identity", "description": "Groups source-qualified participation context for subject kind, profile and protected identity.", "source_refs": [ "SRC-001", "SRC-003", "SRC-004", "SRC-005", "SRC-008", "SRC-016" ], "findings": [ { "id": "subject-kind-unit-of-analysis-species-and-population-profile", "name": "Subject kind, unit of analysis, species and population profile", "description": "Records subject kind, unit of analysis, species and population profile as source-qualified participation context while keeping person, study, protocol, consent artifact, intervention, observation, safety, payment and identity-linkage masters external.", "source_refs": [ "SRC-001", "SRC-003", "SRC-004", "SRC-005", "SRC-008", "SRC-016" ], "questions": [ { "id": "subject-kind-unit-of-analysis-species-and-population-profile-q01", "text": "What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish subject kind, unit of analysis, species and population profile?", "kind": "classification", "answer_data": [ "identifiers, class and participation scope", "source-qualified values and versions", "unknown and not-applicable states" ] }, { "id": "subject-kind-unit-of-analysis-species-and-population-profile-q02", "text": "Who may assert, review, correct or rely on subject kind, unit of analysis, species and population profile, under which authority, purpose and limits?", "kind": "evidence", "answer_data": [ "participant, representative and research roles", "authority, policy, purpose and limits", "review, exception and escalation path" ] }, { "id": "subject-kind-unit-of-analysis-species-and-population-profile-q03", "text": "Which event, effective, recorded, ingested and knowledge times apply to subject kind, unit of analysis, species and population profile, and which evidence supports them?", "kind": "lifecycle", "answer_data": [ "distinct event and knowledge times", "evidence, provenance and uncertainty", "successor correction and retention" ] } ], "data_elements": [ { "id": "subject-kind-unit-of-analysis-species-and-population-profile-data", "name": "Subject kind, unit of analysis, species and population profile data", "description": "Typed data for subject kind, unit of analysis, species and population profile with identity, study scope, source, authority, state, time, evidence and provenance.", "value_kind": "collection", "cardinality": "1", "required": true, "source_refs": [ "SRC-001", "SRC-003", "SRC-004", "SRC-005", "SRC-008", "SRC-016" ] } ], "artifacts": [ { "id": "subject-kind-unit-of-analysis-species-and-population-profile-record", "name": "Subject kind, unit of analysis, species and population profile record", "description": "Immutable or successor-versioned participation evidence for subject kind, unit of analysis, species and population profile.", "media_or_form": [ "logical research-participation assertion", "identity, permission, state, activity, safety, outcome, privacy or projection record" ], "serial": true, "identity_strategy": "Participation ID plus independent assertion or event ID for subject-kind-unit-of-analysis-species-and-population-profile; subject name, study name, date, state, pseudonym and arm never identify a record alone.", "source_refs": [ "SRC-001", "SRC-003", "SRC-004", "SRC-005", "SRC-008", "SRC-016" ] } ], "inline_only_rationale": null }, { "id": "external-subject-master-study-identifiers-pseudonym-and-link-key", "name": "External subject master, study identifiers, pseudonym and link key", "description": "Records external subject master, study identifiers, pseudonym and link key as source-qualified participation context while keeping person, study, protocol, consent artifact, intervention, observation, safety, payment and identity-linkage masters external.", "source_refs": [ "SRC-001", "SRC-003", "SRC-004", "SRC-005", "SRC-008", "SRC-016" ], "questions": [ { "id": "external-subject-master-study-identifiers-pseudonym-and-link-key-q01", "text": "What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish external subject master, study identifiers, pseudonym and link key?", "kind": "security", "answer_data": [ "identifiers, class and participation scope", "source-qualified values and versions", "unknown and not-applicable states" ] }, { "id": "external-subject-master-study-identifiers-pseudonym-and-link-key-q02", "text": "Who may assert, review, correct or rely on external subject master, study identifiers, pseudonym and link key, under which authority, purpose and limits?", "kind": "ownership", "answer_data": [ "participant, representative and research roles", "authority, policy, purpose and limits", "review, exception and escalation path" ] }, { "id": "external-subject-master-study-identifiers-pseudonym-and-link-key-q03", "text": "Which event, effective, recorded, ingested and knowledge times apply to external subject master, study identifiers, pseudonym and link key, and which evidence supports them?", "kind": "quality", "answer_data": [ "distinct event and knowledge times", "evidence, provenance and uncertainty", "successor correction and retention" ] } ], "data_elements": [ { "id": "external-subject-master-study-identifiers-pseudonym-and-link-key-data", "name": "External subject master, study identifiers, pseudonym and link key data", "description": "Typed data for external subject master, study identifiers, pseudonym and link key with identity, study scope, source, authority, state, time, evidence and provenance.", "value_kind": "collection", "cardinality": "1", "required": true, "source_refs": [ "SRC-001", "SRC-003", "SRC-004", "SRC-005", "SRC-008", "SRC-016" ] } ], "artifacts": [ { "id": "external-subject-master-study-identifiers-pseudonym-and-link-key-record", "name": "External subject master, study identifiers, pseudonym and link key record", "description": "Immutable or successor-versioned participation evidence for external subject master, study identifiers, pseudonym and link key.", "media_or_form": [ "logical research-participation assertion", "identity, permission, state, activity, safety, outcome, privacy or projection record" ], "serial": true, "identity_strategy": "Participation ID plus independent assertion or event ID for external-subject-master-study-identifiers-pseudonym-and-link-key; subject name, study name, date, state, pseudonym and arm never identify a record alone.", "source_refs": [ "SRC-001", "SRC-003", "SRC-004", "SRC-005", "SRC-008", "SRC-016" ] } ], "inline_only_rationale": null } ] } ] }, { "id": "recruitment-screening-eligibility-and-consent", "name": "Recruitment, screening, eligibility and consent", "description": "Groups governed participation context for recruitment, screening, eligibility and consent.", "rationale": "Contact, evaluation, permission and enrolment are separate sourced events and decisions.", "source_refs": [ "SRC-001", "SRC-002", "SRC-003", "SRC-004", "SRC-005", "SRC-006", "SRC-010", "SRC-013" ], "layers": [ { "id": "recruitment-prescreening-and-screening", "name": "Recruitment, prescreening and screening", "description": "Groups source-qualified participation context for recruitment, prescreening and screening.", "source_refs": [ "SRC-001", "SRC-003", "SRC-004", "SRC-005", "SRC-006" ], "findings": [ { "id": "recruitment-source-contact-permission-prescreening-and-candidate-state", "name": "Recruitment source, contact permission, prescreening and candidate state", "description": "Records recruitment source, contact permission, prescreening and candidate state as source-qualified participation context while keeping person, study, protocol, consent artifact, intervention, observation, safety, payment and identity-linkage masters external.", "source_refs": [ "SRC-001", "SRC-003", "SRC-004", "SRC-005", "SRC-006" ], "questions": [ { "id": "recruitment-source-contact-permission-prescreening-and-candidate-state-q01", "text": "What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish recruitment source, contact permission, prescreening and candidate state?", "kind": "process", "answer_data": [ "identifiers, class and participation scope", "source-qualified values and versions", "unknown and not-applicable states" ] }, { "id": "recruitment-source-contact-permission-prescreening-and-candidate-state-q02", "text": "Who may assert, review, correct or rely on recruitment source, contact permission, prescreening and candidate state, under which authority, purpose and limits?", "kind": "measurement", "answer_data": [ "participant, representative and research roles", "authority, policy, purpose and limits", "review, exception and escalation path" ] }, { "id": "recruitment-source-contact-permission-prescreening-and-candidate-state-q03", "text": "Which event, effective, recorded, ingested and knowledge times apply to recruitment source, contact permission, prescreening and candidate state, and which evidence supports them?", "kind": "security", "answer_data": [ "distinct event and knowledge times", "evidence, provenance and uncertainty", "successor correction and retention" ] } ], "data_elements": [ { "id": "recruitment-source-contact-permission-prescreening-and-candidate-state-data", "name": "Recruitment source, contact permission, prescreening and candidate state data", "description": "Typed data for recruitment source, contact permission, prescreening and candidate state with identity, study scope, source, authority, state, time, evidence and provenance.", "value_kind": "collection", "cardinality": "0..n", "required": false, "source_refs": [ "SRC-001", "SRC-003", "SRC-004", "SRC-005", "SRC-006" ] } ], "artifacts": [ { "id": "recruitment-source-contact-permission-prescreening-and-candidate-state-record", "name": "Recruitment source, contact permission, prescreening and candidate state record", "description": "Immutable or successor-versioned participation evidence for recruitment source, contact permission, prescreening and candidate state.", "media_or_form": [ "logical research-participation assertion", "identity, permission, state, activity, safety, outcome, privacy or projection record" ], "serial": true, "identity_strategy": "Participation ID plus independent assertion or event ID for recruitment-source-contact-permission-prescreening-and-candidate-state; subject name, study name, date, state, pseudonym and arm never identify a record alone.", "source_refs": [ "SRC-001", "SRC-003", "SRC-004", "SRC-005", "SRC-006" ] } ], "inline_only_rationale": null }, { "id": "screening-event-procedure-result-status-failure-and-rescreening", "name": "Screening event, procedure, result, status, failure and rescreening", "description": "Records screening event, procedure, result, status, failure and rescreening as source-qualified participation context while keeping person, study, protocol, consent artifact, intervention, observation, safety, payment and identity-linkage masters external.", "source_refs": [ "SRC-001", "SRC-003", "SRC-004", "SRC-005", "SRC-006" ], "questions": [ { "id": "screening-event-procedure-result-status-failure-and-rescreening-q01", "text": "What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish screening event, procedure, result, status, failure and rescreening?", "kind": "event", "answer_data": [ "identifiers, class and participation scope", "source-qualified values and versions", "unknown and not-applicable states" ] }, { "id": "screening-event-procedure-result-status-failure-and-rescreening-q02", "text": "Who may assert, review, correct or rely on screening event, procedure, result, status, failure and rescreening, under which authority, purpose and limits?", "kind": "exception", "answer_data": [ "participant, representative and research roles", "authority, policy, purpose and limits", "review, exception and escalation path" ] }, { "id": "screening-event-procedure-result-status-failure-and-rescreening-q03", "text": "Which event, effective, recorded, ingested and knowledge times apply to screening event, procedure, result, status, failure and rescreening, and which evidence supports them?", "kind": "retention", "answer_data": [ "distinct event and knowledge times", "evidence, provenance and uncertainty", "successor correction and retention" ] } ], "data_elements": [ { "id": "screening-event-procedure-result-status-failure-and-rescreening-data", "name": "Screening event, procedure, result, status, failure and rescreening data", "description": "Typed data for screening event, procedure, result, status, failure and rescreening with identity, study scope, source, authority, state, time, evidence and provenance.", "value_kind": "collection", "cardinality": "0..n", "required": false, "source_refs": [ "SRC-001", "SRC-003", "SRC-004", "SRC-005", "SRC-006" ] } ], "artifacts": [ { "id": "screening-event-procedure-result-status-failure-and-rescreening-record", "name": "Screening event, procedure, result, status, failure and rescreening record", "description": "Immutable or successor-versioned participation evidence for screening event, procedure, result, status, failure and rescreening.", "media_or_form": [ "logical research-participation assertion", "identity, permission, state, activity, safety, outcome, privacy or projection record" ], "serial": true, "identity_strategy": "Participation ID plus independent assertion or event ID for screening-event-procedure-result-status-failure-and-rescreening; subject name, study name, date, state, pseudonym and arm never identify a record alone.", "source_refs": [ "SRC-001", "SRC-003", "SRC-004", "SRC-005", "SRC-006" ] } ], "inline_only_rationale": null } ] }, { "id": "eligibility-and-permission", "name": "Eligibility and permission", "description": "Groups source-qualified participation context for eligibility and permission.", "source_refs": [ "SRC-001", "SRC-002", "SRC-003", "SRC-004", "SRC-005", "SRC-006", "SRC-010", "SRC-013" ], "findings": [ { "id": "criterion-evaluation-eligibility-decision-waiver-authority-and-evidence", "name": "Criterion evaluation, eligibility decision, waiver authority and evidence", "description": "Records criterion evaluation, eligibility decision, waiver authority and evidence as source-qualified participation context while keeping person, study, protocol, consent artifact, intervention, observation, safety, payment and identity-linkage masters external.", "source_refs": [ "SRC-001", "SRC-002", "SRC-003", "SRC-004", "SRC-005", "SRC-006", "SRC-010", "SRC-013" ], "questions": [ { "id": "criterion-evaluation-eligibility-decision-waiver-authority-and-evidence-q01", "text": "What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish criterion evaluation, eligibility decision, waiver authority and evidence?", "kind": "decision", "answer_data": [ "identifiers, class and participation scope", "source-qualified values and versions", "unknown and not-applicable states" ] }, { "id": "criterion-evaluation-eligibility-decision-waiver-authority-and-evidence-q02", "text": "Who may assert, review, correct or rely on criterion evaluation, eligibility decision, waiver authority and evidence, under which authority, purpose and limits?", "kind": "provenance", "answer_data": [ "participant, representative and research roles", "authority, policy, purpose and limits", "review, exception and escalation path" ] }, { "id": "criterion-evaluation-eligibility-decision-waiver-authority-and-evidence-q03", "text": "Which event, effective, recorded, ingested and knowledge times apply to criterion evaluation, eligibility decision, waiver authority and evidence, and which evidence supports them?", "kind": "interoperability", "answer_data": [ "distinct event and knowledge times", "evidence, provenance and uncertainty", "successor correction and retention" ] } ], "data_elements": [ { "id": "criterion-evaluation-eligibility-decision-waiver-authority-and-evidence-data", "name": "Criterion evaluation, eligibility decision, waiver authority and evidence data", "description": "Typed data for criterion evaluation, eligibility decision, waiver authority and evidence with identity, study scope, source, authority, state, time, evidence and provenance.", "value_kind": "collection", "cardinality": "1", "required": true, "source_refs": [ "SRC-001", "SRC-002", "SRC-003", "SRC-004", "SRC-005", "SRC-006", "SRC-010", "SRC-013" ] } ], "artifacts": [ { "id": "criterion-evaluation-eligibility-decision-waiver-authority-and-evidence-record", "name": "Criterion evaluation, eligibility decision, waiver authority and evidence record", "description": "Immutable or successor-versioned participation evidence for criterion evaluation, eligibility decision, waiver authority and evidence.", "media_or_form": [ "logical research-participation assertion", "identity, permission, state, activity, safety, outcome, privacy or projection record" ], "serial": true, "identity_strategy": "Participation ID plus independent assertion or event ID for criterion-evaluation-eligibility-decision-waiver-authority-and-evidence; subject name, study name, date, state, pseudonym and arm never identify a record alone.", "source_refs": [ "SRC-001", "SRC-002", "SRC-003", "SRC-004", "SRC-005", "SRC-006", "SRC-010", "SRC-013" ] } ], "inline_only_rationale": null }, { "id": "consent-assent-representative-permission-reconsent-refusal-and-source", "name": "Consent, assent, representative permission, reconsent, refusal and source", "description": "Records consent, assent, representative permission, reconsent, refusal and source as source-qualified participation context while keeping person, study, protocol, consent artifact, intervention, observation, safety, payment and identity-linkage masters external.", "source_refs": [ "SRC-001", "SRC-002", "SRC-003", "SRC-004", "SRC-005", "SRC-006", "SRC-010", "SRC-013" ], "questions": [ { "id": "consent-assent-representative-permission-reconsent-refusal-and-source-q01", "text": "What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish consent, assent, representative permission, reconsent, refusal and source?", "kind": "authority", "answer_data": [ "identifiers, class and participation scope", "source-qualified values and versions", "unknown and not-applicable states" ] }, { "id": "consent-assent-representative-permission-reconsent-refusal-and-source-q02", "text": "Who may assert, review, correct or rely on consent, assent, representative permission, reconsent, refusal and source, under which authority, purpose and limits?", "kind": "process", "answer_data": [ "participant, representative and research roles", "authority, policy, purpose and limits", "review, exception and escalation path" ] }, { "id": "consent-assent-representative-permission-reconsent-refusal-and-source-q03", "text": "Which event, effective, recorded, ingested and knowledge times apply to consent, assent, representative permission, reconsent, refusal and source, and which evidence supports them?", "kind": "decision", "answer_data": [ "distinct event and knowledge times", "evidence, provenance and uncertainty", "successor correction and retention" ] } ], "data_elements": [ { "id": "consent-assent-representative-permission-reconsent-refusal-and-source-data", "name": "Consent, assent, representative permission, reconsent, refusal and source data", "description": "Typed data for consent, assent, representative permission, reconsent, refusal and source with identity, study scope, source, authority, state, time, evidence and provenance.", "value_kind": "collection", "cardinality": "1", "required": true, "source_refs": [ "SRC-001", "SRC-002", "SRC-003", "SRC-004", "SRC-005", "SRC-006", "SRC-010", "SRC-013" ] } ], "artifacts": [ { "id": "consent-assent-representative-permission-reconsent-refusal-and-source-record", "name": "Consent, assent, representative permission, reconsent, refusal and source record", "description": "Immutable or successor-versioned participation evidence for consent, assent, representative permission, reconsent, refusal and source.", "media_or_form": [ "logical research-participation assertion", "identity, permission, state, activity, safety, outcome, privacy or projection record" ], "serial": true, "identity_strategy": "Participation ID plus independent assertion or event ID for consent-assent-representative-permission-reconsent-refusal-and-source; subject name, study name, date, state, pseudonym and arm never identify a record alone.", "source_refs": [ "SRC-001", "SRC-002", "SRC-003", "SRC-004", "SRC-005", "SRC-006", "SRC-010", "SRC-013" ] } ], "inline_only_rationale": null } ] } ] }, { "id": "enrolment-allocation-blinding-and-participation-plan", "name": "Enrolment, allocation, blinding and participation plan", "description": "Groups governed participation context for enrolment, allocation, blinding and participation plan.", "rationale": "Entry into a study, assignment and the planned path require independent identity, authority and timing.", "source_refs": [ "SRC-001", "SRC-002", "SRC-004", "SRC-006", "SRC-007", "SRC-008", "SRC-009", "SRC-011", "SRC-012", "SRC-013" ], "layers": [ { "id": "enrolment-randomization-allocation-and-blinding", "name": "Enrolment, randomization, allocation and blinding", "description": "Groups source-qualified participation context for enrolment, randomization, allocation and blinding.", "source_refs": [ "SRC-001", "SRC-004", "SRC-006", "SRC-007", "SRC-008", "SRC-013" ], "findings": [ { "id": "enrolment-event-identifier-site-date-authority-and-prerequisites", "name": "Enrolment event, identifier, site, date, authority and prerequisites", "description": "Records enrolment event, identifier, site, date, authority and prerequisites as source-qualified participation context while keeping person, study, protocol, consent artifact, intervention, observation, safety, payment and identity-linkage masters external.", "source_refs": [ "SRC-001", "SRC-004", "SRC-006", "SRC-007", "SRC-008", "SRC-013" ], "questions": [ { "id": "enrolment-event-identifier-site-date-authority-and-prerequisites-q01", "text": "What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish enrolment event, identifier, site, date, authority and prerequisites?", "kind": "lifecycle", "answer_data": [ "identifiers, class and participation scope", "source-qualified values and versions", "unknown and not-applicable states" ] }, { "id": "enrolment-event-identifier-site-date-authority-and-prerequisites-q02", "text": "Who may assert, review, correct or rely on enrolment event, identifier, site, date, authority and prerequisites, under which authority, purpose and limits?", "kind": "validation", "answer_data": [ "participant, representative and research roles", "authority, policy, purpose and limits", "review, exception and escalation path" ] }, { "id": "enrolment-event-identifier-site-date-authority-and-prerequisites-q03", "text": "Which event, effective, recorded, ingested and knowledge times apply to enrolment event, identifier, site, date, authority and prerequisites, and which evidence supports them?", "kind": "state", "answer_data": [ "distinct event and knowledge times", "evidence, provenance and uncertainty", "successor correction and retention" ] } ], "data_elements": [ { "id": "enrolment-event-identifier-site-date-authority-and-prerequisites-data", "name": "Enrolment event, identifier, site, date, authority and prerequisites data", "description": "Typed data for enrolment event, identifier, site, date, authority and prerequisites with identity, study scope, source, authority, state, time, evidence and provenance.", "value_kind": "collection", "cardinality": "1", "required": true, "source_refs": [ "SRC-001", "SRC-004", "SRC-006", "SRC-007", "SRC-008", "SRC-013" ] } ], "artifacts": [ { "id": "enrolment-event-identifier-site-date-authority-and-prerequisites-record", "name": "Enrolment event, identifier, site, date, authority and prerequisites record", "description": "Immutable or successor-versioned participation evidence for enrolment event, identifier, site, date, authority and prerequisites.", "media_or_form": [ "logical research-participation assertion", "identity, permission, state, activity, safety, outcome, privacy or projection record" ], "serial": true, "identity_strategy": "Participation ID plus independent assertion or event ID for enrolment-event-identifier-site-date-authority-and-prerequisites; subject name, study name, date, state, pseudonym and arm never identify a record alone.", "source_refs": [ "SRC-001", "SRC-004", "SRC-006", "SRC-007", "SRC-008", "SRC-013" ] } ], "inline_only_rationale": null }, { "id": "randomization-stratum-allocation-concealment-assigned-arm-and-blinding", "name": "Randomization, stratum, allocation concealment, assigned arm and blinding", "description": "Records randomization, stratum, allocation concealment, assigned arm and blinding as source-qualified participation context while keeping person, study, protocol, consent artifact, intervention, observation, safety, payment and identity-linkage masters external.", "source_refs": [ "SRC-001", "SRC-004", "SRC-006", "SRC-007", "SRC-008", "SRC-013" ], "questions": [ { "id": "randomization-stratum-allocation-concealment-assigned-arm-and-blinding-q01", "text": "What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish randomization, stratum, allocation concealment, assigned arm and blinding?", "kind": "security", "answer_data": [ "identifiers, class and participation scope", "source-qualified values and versions", "unknown and not-applicable states" ] }, { "id": "randomization-stratum-allocation-concealment-assigned-arm-and-blinding-q02", "text": "Who may assert, review, correct or rely on randomization, stratum, allocation concealment, assigned arm and blinding, under which authority, purpose and limits?", "kind": "privacy", "answer_data": [ "participant, representative and research roles", "authority, policy, purpose and limits", "review, exception and escalation path" ] }, { "id": "randomization-stratum-allocation-concealment-assigned-arm-and-blinding-q03", "text": "Which event, effective, recorded, ingested and knowledge times apply to randomization, stratum, allocation concealment, assigned arm and blinding, and which evidence supports them?", "kind": "identity", "answer_data": [ "distinct event and knowledge times", "evidence, provenance and uncertainty", "successor correction and retention" ] } ], "data_elements": [ { "id": "randomization-stratum-allocation-concealment-assigned-arm-and-blinding-data", "name": "Randomization, stratum, allocation concealment, assigned arm and blinding data", "description": "Typed data for randomization, stratum, allocation concealment, assigned arm and blinding with identity, study scope, source, authority, state, time, evidence and provenance.", "value_kind": "collection", "cardinality": "0..n", "required": false, "source_refs": [ "SRC-001", "SRC-004", "SRC-006", "SRC-007", "SRC-008", "SRC-013" ] } ], "artifacts": [ { "id": "randomization-stratum-allocation-concealment-assigned-arm-and-blinding-record", "name": "Randomization, stratum, allocation concealment, assigned arm and blinding record", "description": "Immutable or successor-versioned participation evidence for randomization, stratum, allocation concealment, assigned arm and blinding.", "media_or_form": [ "logical research-participation assertion", "identity, permission, state, activity, safety, outcome, privacy or projection record" ], "serial": true, "identity_strategy": "Participation ID plus independent assertion or event ID for randomization-stratum-allocation-concealment-assigned-arm-and-blinding; subject name, study name, date, state, pseudonym and arm never identify a record alone.", "source_refs": [ "SRC-001", "SRC-004", "SRC-006", "SRC-007", "SRC-008", "SRC-013" ] } ], "inline_only_rationale": null } ] }, { "id": "planned-path-periods-visits-and-activities", "name": "Planned path, periods, visits and activities", "description": "Groups source-qualified participation context for planned path, periods, visits and activities.", "source_refs": [ "SRC-001", "SRC-002", "SRC-008", "SRC-009", "SRC-011", "SRC-012" ], "findings": [ { "id": "planned-arm-cohort-comparison-group-and-participation-period", "name": "Planned arm, cohort, comparison group and participation period", "description": "Records planned arm, cohort, comparison group and participation period as source-qualified participation context while keeping person, study, protocol, consent artifact, intervention, observation, safety, payment and identity-linkage masters external.", "source_refs": [ "SRC-001", "SRC-002", "SRC-008", "SRC-009", "SRC-011", "SRC-012" ], "questions": [ { "id": "planned-arm-cohort-comparison-group-and-participation-period-q01", "text": "What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish planned arm, cohort, comparison group and participation period?", "kind": "composition", "answer_data": [ "identifiers, class and participation scope", "source-qualified values and versions", "unknown and not-applicable states" ] }, { "id": "planned-arm-cohort-comparison-group-and-participation-period-q02", "text": "Who may assert, review, correct or rely on planned arm, cohort, comparison group and participation period, under which authority, purpose and limits?", "kind": "lifecycle", "answer_data": [ "participant, representative and research roles", "authority, policy, purpose and limits", "review, exception and escalation path" ] }, { "id": "planned-arm-cohort-comparison-group-and-participation-period-q03", "text": "Which event, effective, recorded, ingested and knowledge times apply to planned arm, cohort, comparison group and participation period, and which evidence supports them?", "kind": "classification", "answer_data": [ "distinct event and knowledge times", "evidence, provenance and uncertainty", "successor correction and retention" ] } ], "data_elements": [ { "id": "planned-arm-cohort-comparison-group-and-participation-period-data", "name": "Planned arm, cohort, comparison group and participation period data", "description": "Typed data for planned arm, cohort, comparison group and participation period with identity, study scope, source, authority, state, time, evidence and provenance.", "value_kind": "collection", "cardinality": "0..n", "required": false, "source_refs": [ "SRC-001", "SRC-002", "SRC-008", "SRC-009", "SRC-011", "SRC-012" ] } ], "artifacts": [ { "id": "planned-arm-cohort-comparison-group-and-participation-period-record", "name": "Planned arm, cohort, comparison group and participation period record", "description": "Immutable or successor-versioned participation evidence for planned arm, cohort, comparison group and participation period.", "media_or_form": [ "logical research-participation assertion", "identity, permission, state, activity, safety, outcome, privacy or projection record" ], "serial": true, "identity_strategy": "Participation ID plus independent assertion or event ID for planned-arm-cohort-comparison-group-and-participation-period; subject name, study name, date, state, pseudonym and arm never identify a record alone.", "source_refs": [ "SRC-001", "SRC-002", "SRC-008", "SRC-009", "SRC-011", "SRC-012" ] } ], "inline_only_rationale": null }, { "id": "planned-visit-activity-intervention-observation-and-window", "name": "Planned visit, activity, intervention, observation and window", "description": "Records planned visit, activity, intervention, observation and window as source-qualified participation context while keeping person, study, protocol, consent artifact, intervention, observation, safety, payment and identity-linkage masters external.", "source_refs": [ "SRC-001", "SRC-002", "SRC-008", "SRC-009", "SRC-011", "SRC-012" ], "questions": [ { "id": "planned-visit-activity-intervention-observation-and-window-q01", "text": "What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish planned visit, activity, intervention, observation and window?", "kind": "requirement", "answer_data": [ "identifiers, class and participation scope", "source-qualified values and versions", "unknown and not-applicable states" ] }, { "id": "planned-visit-activity-intervention-observation-and-window-q02", "text": "Who may assert, review, correct or rely on planned visit, activity, intervention, observation and window, under which authority, purpose and limits?", "kind": "quality", "answer_data": [ "participant, representative and research roles", "authority, policy, purpose and limits", "review, exception and escalation path" ] }, { "id": "planned-visit-activity-intervention-observation-and-window-q03", "text": "Which event, effective, recorded, ingested and knowledge times apply to planned visit, activity, intervention, observation and window, and which evidence supports them?", "kind": "relationship", "answer_data": [ "distinct event and knowledge times", "evidence, provenance and uncertainty", "successor correction and retention" ] } ], "data_elements": [ { "id": "planned-visit-activity-intervention-observation-and-window-data", "name": "Planned visit, activity, intervention, observation and window data", "description": "Typed data for planned visit, activity, intervention, observation and window with identity, study scope, source, authority, state, time, evidence and provenance.", "value_kind": "collection", "cardinality": "0..n", "required": false, "source_refs": [ "SRC-001", "SRC-002", "SRC-008", "SRC-009", "SRC-011", "SRC-012" ] } ], "artifacts": [ { "id": "planned-visit-activity-intervention-observation-and-window-record", "name": "Planned visit, activity, intervention, observation and window record", "description": "Immutable or successor-versioned participation evidence for planned visit, activity, intervention, observation and window.", "media_or_form": [ "logical research-participation assertion", "identity, permission, state, activity, safety, outcome, privacy or projection record" ], "serial": true, "identity_strategy": "Participation ID plus independent assertion or event ID for planned-visit-activity-intervention-observation-and-window; subject name, study name, date, state, pseudonym and arm never identify a record alone.", "source_refs": [ "SRC-001", "SRC-002", "SRC-008", "SRC-009", "SRC-011", "SRC-012" ] } ], "inline_only_rationale": null } ] } ] }, { "id": "actual-participation-safety-adherence-and-compensation", "name": "Actual participation, safety, adherence and compensation", "description": "Groups governed participation context for actual participation, safety, adherence and compensation.", "rationale": "What happened must remain distinct from assignments, expected activities and conclusions.", "source_refs": [ "SRC-001", "SRC-002", "SRC-003", "SRC-004", "SRC-006", "SRC-008", "SRC-011", "SRC-012", "SRC-013", "SRC-015" ], "layers": [ { "id": "actual-activities-exposure-adherence-and-deviation", "name": "Actual activities, exposure, adherence and deviation", "description": "Groups source-qualified participation context for actual activities, exposure, adherence and deviation.", "source_refs": [ "SRC-001", "SRC-002", "SRC-006", "SRC-008", "SRC-011", "SRC-012", "SRC-015" ], "findings": [ { "id": "actual-visit-activity-intervention-exposure-dose-and-observation-reference", "name": "Actual visit, activity, intervention, exposure, dose and observation reference", "description": "Records actual visit, activity, intervention, exposure, dose and observation reference as source-qualified participation context while keeping person, study, protocol, consent artifact, intervention, observation, safety, payment and identity-linkage masters external.", "source_refs": [ "SRC-001", "SRC-002", "SRC-006", "SRC-008", "SRC-011", "SRC-012", "SRC-015" ], "questions": [ { "id": "actual-visit-activity-intervention-exposure-dose-and-observation-reference-q01", "text": "What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish actual visit, activity, intervention, exposure, dose and observation reference?", "kind": "evidence", "answer_data": [ "identifiers, class and participation scope", "source-qualified values and versions", "unknown and not-applicable states" ] }, { "id": "actual-visit-activity-intervention-exposure-dose-and-observation-reference-q02", "text": "Who may assert, review, correct or rely on actual visit, activity, intervention, exposure, dose and observation reference, under which authority, purpose and limits?", "kind": "security", "answer_data": [ "participant, representative and research roles", "authority, policy, purpose and limits", "review, exception and escalation path" ] }, { "id": "actual-visit-activity-intervention-exposure-dose-and-observation-reference-q03", "text": "Which event, effective, recorded, ingested and knowledge times apply to actual visit, activity, intervention, exposure, dose and observation reference, and which evidence supports them?", "kind": "authority", "answer_data": [ "distinct event and knowledge times", "evidence, provenance and uncertainty", "successor correction and retention" ] } ], "data_elements": [ { "id": "actual-visit-activity-intervention-exposure-dose-and-observation-reference-data", "name": "Actual visit, activity, intervention, exposure, dose and observation reference data", "description": "Typed data for actual visit, activity, intervention, exposure, dose and observation reference with identity, study scope, source, authority, state, time, evidence and provenance.", "value_kind": "collection", "cardinality": "0..n", "required": false, "source_refs": [ "SRC-001", "SRC-002", "SRC-006", "SRC-008", "SRC-011", "SRC-012", "SRC-015" ] } ], "artifacts": [ { "id": "actual-visit-activity-intervention-exposure-dose-and-observation-reference-record", "name": "Actual visit, activity, intervention, exposure, dose and observation reference record", "description": "Immutable or successor-versioned participation evidence for actual visit, activity, intervention, exposure, dose and observation reference.", "media_or_form": [ "logical research-participation assertion", "identity, permission, state, activity, safety, outcome, privacy or projection record" ], "serial": true, "identity_strategy": "Participation ID plus independent assertion or event ID for actual-visit-activity-intervention-exposure-dose-and-observation-reference; subject name, study name, date, state, pseudonym and arm never identify a record alone.", "source_refs": [ "SRC-001", "SRC-002", "SRC-006", "SRC-008", "SRC-011", "SRC-012", "SRC-015" ] } ], "inline_only_rationale": null }, { "id": "attendance-adherence-nonadherence-protocol-deviation-and-impact", "name": "Attendance, adherence, nonadherence, protocol deviation and impact", "description": "Records attendance, adherence, nonadherence, protocol deviation and impact as source-qualified participation context while keeping person, study, protocol, consent artifact, intervention, observation, safety, payment and identity-linkage masters external.", "source_refs": [ "SRC-001", "SRC-002", "SRC-006", "SRC-008", "SRC-011", "SRC-012", "SRC-015" ], "questions": [ { "id": "attendance-adherence-nonadherence-protocol-deviation-and-impact-q01", "text": "What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish attendance, adherence, nonadherence, protocol deviation and impact?", "kind": "quality", "answer_data": [ "identifiers, class and participation scope", "source-qualified values and versions", "unknown and not-applicable states" ] }, { "id": "attendance-adherence-nonadherence-protocol-deviation-and-impact-q02", "text": "Who may assert, review, correct or rely on attendance, adherence, nonadherence, protocol deviation and impact, under which authority, purpose and limits?", "kind": "retention", "answer_data": [ "participant, representative and research roles", "authority, policy, purpose and limits", "review, exception and escalation path" ] }, { "id": "attendance-adherence-nonadherence-protocol-deviation-and-impact-q03", "text": "Which event, effective, recorded, ingested and knowledge times apply to attendance, adherence, nonadherence, protocol deviation and impact, and which evidence supports them?", "kind": "requirement", "answer_data": [ "distinct event and knowledge times", "evidence, provenance and uncertainty", "successor correction and retention" ] } ], "data_elements": [ { "id": "attendance-adherence-nonadherence-protocol-deviation-and-impact-data", "name": "Attendance, adherence, nonadherence, protocol deviation and impact data", "description": "Typed data for attendance, adherence, nonadherence, protocol deviation and impact with identity, study scope, source, authority, state, time, evidence and provenance.", "value_kind": "collection", "cardinality": "0..n", "required": false, "source_refs": [ "SRC-001", "SRC-002", "SRC-006", "SRC-008", "SRC-011", "SRC-012", "SRC-015" ] } ], "artifacts": [ { "id": "attendance-adherence-nonadherence-protocol-deviation-and-impact-record", "name": "Attendance, adherence, nonadherence, protocol deviation and impact record", "description": "Immutable or successor-versioned participation evidence for attendance, adherence, nonadherence, protocol deviation and impact.", "media_or_form": [ "logical research-participation assertion", "identity, permission, state, activity, safety, outcome, privacy or projection record" ], "serial": true, "identity_strategy": "Participation ID plus independent assertion or event ID for attendance-adherence-nonadherence-protocol-deviation-and-impact; subject name, study name, date, state, pseudonym and arm never identify a record alone.", "source_refs": [ "SRC-001", "SRC-002", "SRC-006", "SRC-008", "SRC-011", "SRC-012", "SRC-015" ] } ], "inline_only_rationale": null } ] }, { "id": "safety-incidents-medical-care-and-compensation", "name": "Safety, incidents, medical care and compensation", "description": "Groups source-qualified participation context for safety, incidents, medical care and compensation.", "source_refs": [ "SRC-001", "SRC-003", "SRC-004", "SRC-006", "SRC-013" ], "findings": [ { "id": "safety-observation-adverse-event-seriousness-causality-and-report-reference", "name": "Safety observation, adverse event, seriousness, causality and report reference", "description": "Records safety observation, adverse event, seriousness, causality and report reference as source-qualified participation context while keeping person, study, protocol, consent artifact, intervention, observation, safety, payment and identity-linkage masters external.", "source_refs": [ "SRC-001", "SRC-003", "SRC-004", "SRC-006", "SRC-013" ], "questions": [ { "id": "safety-observation-adverse-event-seriousness-causality-and-report-reference-q01", "text": "What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish safety observation, adverse event, seriousness, causality and report reference?", "kind": "evidence", "answer_data": [ "identifiers, class and participation scope", "source-qualified values and versions", "unknown and not-applicable states" ] }, { "id": "safety-observation-adverse-event-seriousness-causality-and-report-reference-q02", "text": "Who may assert, review, correct or rely on safety observation, adverse event, seriousness, causality and report reference, under which authority, purpose and limits?", "kind": "interoperability", "answer_data": [ "participant, representative and research roles", "authority, policy, purpose and limits", "review, exception and escalation path" ] }, { "id": "safety-observation-adverse-event-seriousness-causality-and-report-reference-q03", "text": "Which event, effective, recorded, ingested and knowledge times apply to safety observation, adverse event, seriousness, causality and report reference, and which evidence supports them?", "kind": "constraint", "answer_data": [ "distinct event and knowledge times", "evidence, provenance and uncertainty", "successor correction and retention" ] } ], "data_elements": [ { "id": "safety-observation-adverse-event-seriousness-causality-and-report-reference-data", "name": "Safety observation, adverse event, seriousness, causality and report reference data", "description": "Typed data for safety observation, adverse event, seriousness, causality and report reference with identity, study scope, source, authority, state, time, evidence and provenance.", "value_kind": "collection", "cardinality": "0..n", "required": false, "source_refs": [ "SRC-001", "SRC-003", "SRC-004", "SRC-006", "SRC-013" ] } ], "artifacts": [ { "id": "safety-observation-adverse-event-seriousness-causality-and-report-reference-record", "name": "Safety observation, adverse event, seriousness, causality and report reference record", "description": "Immutable or successor-versioned participation evidence for safety observation, adverse event, seriousness, causality and report reference.", "media_or_form": [ "logical research-participation assertion", "identity, permission, state, activity, safety, outcome, privacy or projection record" ], "serial": true, "identity_strategy": "Participation ID plus independent assertion or event ID for safety-observation-adverse-event-seriousness-causality-and-report-reference; subject name, study name, date, state, pseudonym and arm never identify a record alone.", "source_refs": [ "SRC-001", "SRC-003", "SRC-004", "SRC-006", "SRC-013" ] } ], "inline_only_rationale": null }, { "id": "research-injury-medical-care-compensation-reimbursement-and-payment-reference", "name": "Research injury, medical care, compensation, reimbursement and payment reference", "description": "Records research injury, medical care, compensation, reimbursement and payment reference as source-qualified participation context while keeping person, study, protocol, consent artifact, intervention, observation, safety, payment and identity-linkage masters external.", "source_refs": [ "SRC-001", "SRC-003", "SRC-004", "SRC-006", "SRC-013" ], "questions": [ { "id": "research-injury-medical-care-compensation-reimbursement-and-payment-reference-q01", "text": "What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish research injury, medical care, compensation, reimbursement and payment reference?", "kind": "relationship", "answer_data": [ "identifiers, class and participation scope", "source-qualified values and versions", "unknown and not-applicable states" ] }, { "id": "research-injury-medical-care-compensation-reimbursement-and-payment-reference-q02", "text": "Who may assert, review, correct or rely on research injury, medical care, compensation, reimbursement and payment reference, under which authority, purpose and limits?", "kind": "decision", "answer_data": [ "participant, representative and research roles", "authority, policy, purpose and limits", "review, exception and escalation path" ] }, { "id": "research-injury-medical-care-compensation-reimbursement-and-payment-reference-q03", "text": "Which event, effective, recorded, ingested and knowledge times apply to research injury, medical care, compensation, reimbursement and payment reference, and which evidence supports them?", "kind": "event", "answer_data": [ "distinct event and knowledge times", "evidence, provenance and uncertainty", "successor correction and retention" ] } ], "data_elements": [ { "id": "research-injury-medical-care-compensation-reimbursement-and-payment-reference-data", "name": "Research injury, medical care, compensation, reimbursement and payment reference data", "description": "Typed data for research injury, medical care, compensation, reimbursement and payment reference with identity, study scope, source, authority, state, time, evidence and provenance.", "value_kind": "collection", "cardinality": "0..n", "required": false, "source_refs": [ "SRC-001", "SRC-003", "SRC-004", "SRC-006", "SRC-013" ] } ], "artifacts": [ { "id": "research-injury-medical-care-compensation-reimbursement-and-payment-reference-record", "name": "Research injury, medical care, compensation, reimbursement and payment reference record", "description": "Immutable or successor-versioned participation evidence for research injury, medical care, compensation, reimbursement and payment reference.", "media_or_form": [ "logical research-participation assertion", "identity, permission, state, activity, safety, outcome, privacy or projection record" ], "serial": true, "identity_strategy": "Participation ID plus independent assertion or event ID for research-injury-medical-care-compensation-reimbursement-and-payment-reference; subject name, study name, date, state, pseudonym and arm never identify a record alone.", "source_refs": [ "SRC-001", "SRC-003", "SRC-004", "SRC-006", "SRC-013" ] } ], "inline_only_rationale": null } ] } ] }, { "id": "status-outcome-withdrawal-followup-and-data-use", "name": "Status, outcome, withdrawal, follow-up and data use", "description": "Groups governed participation context for status, outcome, withdrawal, follow-up and data use.", "rationale": "Participation status and exit semantics must preserve scope, reason, authority and post-exit obligations.", "source_refs": [ "SRC-001", "SRC-003", "SRC-004", "SRC-006", "SRC-008", "SRC-010", "SRC-013", "SRC-015", "SRC-016" ], "layers": [ { "id": "states-milestones-holds-and-study-effects", "name": "States, milestones, holds and study effects", "description": "Groups source-qualified participation context for states, milestones, holds and study effects.", "source_refs": [ "SRC-001", "SRC-004", "SRC-006", "SRC-008", "SRC-013", "SRC-015" ], "findings": [ { "id": "candidate-screened-eligible-consented-enrolled-active-and-followup-state", "name": "Candidate, screened, eligible, consented, enrolled, active and follow-up state", "description": "Records candidate, screened, eligible, consented, enrolled, active and follow-up state as source-qualified participation context while keeping person, study, protocol, consent artifact, intervention, observation, safety, payment and identity-linkage masters external.", "source_refs": [ "SRC-001", "SRC-004", "SRC-006", "SRC-008", "SRC-013", "SRC-015" ], "questions": [ { "id": "candidate-screened-eligible-consented-enrolled-active-and-followup-state-q01", "text": "What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish candidate, screened, eligible, consented, enrolled, active and follow-up state?", "kind": "state", "answer_data": [ "identifiers, class and participation scope", "source-qualified values and versions", "unknown and not-applicable states" ] }, { "id": "candidate-screened-eligible-consented-enrolled-active-and-followup-state-q02", "text": "Who may assert, review, correct or rely on candidate, screened, eligible, consented, enrolled, active and follow-up state, under which authority, purpose and limits?", "kind": "state", "answer_data": [ "participant, representative and research roles", "authority, policy, purpose and limits", "review, exception and escalation path" ] }, { "id": "candidate-screened-eligible-consented-enrolled-active-and-followup-state-q03", "text": "Which event, effective, recorded, ingested and knowledge times apply to candidate, screened, eligible, consented, enrolled, active and follow-up state, and which evidence supports them?", "kind": "temporal", "answer_data": [ "distinct event and knowledge times", "evidence, provenance and uncertainty", "successor correction and retention" ] } ], "data_elements": [ { "id": "candidate-screened-eligible-consented-enrolled-active-and-followup-state-data", "name": "Candidate, screened, eligible, consented, enrolled, active and follow-up state data", "description": "Typed data for candidate, screened, eligible, consented, enrolled, active and follow-up state with identity, study scope, source, authority, state, time, evidence and provenance.", "value_kind": "collection", "cardinality": "1", "required": true, "source_refs": [ "SRC-001", "SRC-004", "SRC-006", "SRC-008", "SRC-013", "SRC-015" ] } ], "artifacts": [ { "id": "candidate-screened-eligible-consented-enrolled-active-and-followup-state-record", "name": "Candidate, screened, eligible, consented, enrolled, active and follow-up state record", "description": "Immutable or successor-versioned participation evidence for candidate, screened, eligible, consented, enrolled, active and follow-up state.", "media_or_form": [ "logical research-participation assertion", "identity, permission, state, activity, safety, outcome, privacy or projection record" ], "serial": true, "identity_strategy": "Participation ID plus independent assertion or event ID for candidate-screened-eligible-consented-enrolled-active-and-followup-state; subject name, study name, date, state, pseudonym and arm never identify a record alone.", "source_refs": [ "SRC-001", "SRC-004", "SRC-006", "SRC-008", "SRC-013", "SRC-015" ] } ], "inline_only_rationale": null }, { "id": "milestone-hold-suspension-site-closure-study-termination-and-subject-effect", "name": "Milestone, hold, suspension, site closure, study termination and subject effect", "description": "Records milestone, hold, suspension, site closure, study termination and subject effect as source-qualified participation context while keeping person, study, protocol, consent artifact, intervention, observation, safety, payment and identity-linkage masters external.", "source_refs": [ "SRC-001", "SRC-004", "SRC-006", "SRC-008", "SRC-013", "SRC-015" ], "questions": [ { "id": "milestone-hold-suspension-site-closure-study-termination-and-subject-effect-q01", "text": "What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish milestone, hold, suspension, site closure, study termination and subject effect?", "kind": "event", "answer_data": [ "identifiers, class and participation scope", "source-qualified values and versions", "unknown and not-applicable states" ] }, { "id": "milestone-hold-suspension-site-closure-study-termination-and-subject-effect-q02", "text": "Who may assert, review, correct or rely on milestone, hold, suspension, site closure, study termination and subject effect, under which authority, purpose and limits?", "kind": "identity", "answer_data": [ "participant, representative and research roles", "authority, policy, purpose and limits", "review, exception and escalation path" ] }, { "id": "milestone-hold-suspension-site-closure-study-termination-and-subject-effect-q03", "text": "Which event, effective, recorded, ingested and knowledge times apply to milestone, hold, suspension, site closure, study termination and subject effect, and which evidence supports them?", "kind": "composition", "answer_data": [ "distinct event and knowledge times", "evidence, provenance and uncertainty", "successor correction and retention" ] } ], "data_elements": [ { "id": "milestone-hold-suspension-site-closure-study-termination-and-subject-effect-data", "name": "Milestone, hold, suspension, site closure, study termination and subject effect data", "description": "Typed data for milestone, hold, suspension, site closure, study termination and subject effect with identity, study scope, source, authority, state, time, evidence and provenance.", "value_kind": "collection", "cardinality": "0..n", "required": false, "source_refs": [ "SRC-001", "SRC-004", "SRC-006", "SRC-008", "SRC-013", "SRC-015" ] } ], "artifacts": [ { "id": "milestone-hold-suspension-site-closure-study-termination-and-subject-effect-record", "name": "Milestone, hold, suspension, site closure, study termination and subject effect record", "description": "Immutable or successor-versioned participation evidence for milestone, hold, suspension, site closure, study termination and subject effect.", "media_or_form": [ "logical research-participation assertion", "identity, permission, state, activity, safety, outcome, privacy or projection record" ], "serial": true, "identity_strategy": "Participation ID plus independent assertion or event ID for milestone-hold-suspension-site-closure-study-termination-and-subject-effect; subject name, study name, date, state, pseudonym and arm never identify a record alone.", "source_refs": [ "SRC-001", "SRC-004", "SRC-006", "SRC-008", "SRC-013", "SRC-015" ] } ], "inline_only_rationale": null } ] }, { "id": "withdrawal-discontinuation-loss-completion-and-disposition", "name": "Withdrawal, discontinuation, loss, completion and disposition", "description": "Groups source-qualified participation context for withdrawal, discontinuation, loss, completion and disposition.", "source_refs": [ "SRC-001", "SRC-003", "SRC-004", "SRC-006", "SRC-008", "SRC-010", "SRC-016" ], "findings": [ { "id": "refusal-withdrawal-scope-intervention-discontinuation-and-reason", "name": "Refusal, withdrawal scope, intervention discontinuation and reason", "description": "Records refusal, withdrawal scope, intervention discontinuation and reason as source-qualified participation context while keeping person, study, protocol, consent artifact, intervention, observation, safety, payment and identity-linkage masters external.", "source_refs": [ "SRC-001", "SRC-003", "SRC-004", "SRC-006", "SRC-008", "SRC-010", "SRC-016" ], "questions": [ { "id": "refusal-withdrawal-scope-intervention-discontinuation-and-reason-q01", "text": "What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish refusal, withdrawal scope, intervention discontinuation and reason?", "kind": "lifecycle", "answer_data": [ "identifiers, class and participation scope", "source-qualified values and versions", "unknown and not-applicable states" ] }, { "id": "refusal-withdrawal-scope-intervention-discontinuation-and-reason-q02", "text": "Who may assert, review, correct or rely on refusal, withdrawal scope, intervention discontinuation and reason, under which authority, purpose and limits?", "kind": "classification", "answer_data": [ "participant, representative and research roles", "authority, policy, purpose and limits", "review, exception and escalation path" ] }, { "id": "refusal-withdrawal-scope-intervention-discontinuation-and-reason-q03", "text": "Which event, effective, recorded, ingested and knowledge times apply to refusal, withdrawal scope, intervention discontinuation and reason, and which evidence supports them?", "kind": "evidence", "answer_data": [ "distinct event and knowledge times", "evidence, provenance and uncertainty", "successor correction and retention" ] } ], "data_elements": [ { "id": "refusal-withdrawal-scope-intervention-discontinuation-and-reason-data", "name": "Refusal, withdrawal scope, intervention discontinuation and reason data", "description": "Typed data for refusal, withdrawal scope, intervention discontinuation and reason with identity, study scope, source, authority, state, time, evidence and provenance.", "value_kind": "collection", "cardinality": "0..n", "required": false, "source_refs": [ "SRC-001", "SRC-003", "SRC-004", "SRC-006", "SRC-008", "SRC-010", "SRC-016" ] } ], "artifacts": [ { "id": "refusal-withdrawal-scope-intervention-discontinuation-and-reason-record", "name": "Refusal, withdrawal scope, intervention discontinuation and reason record", "description": "Immutable or successor-versioned participation evidence for refusal, withdrawal scope, intervention discontinuation and reason.", "media_or_form": [ "logical research-participation assertion", "identity, permission, state, activity, safety, outcome, privacy or projection record" ], "serial": true, "identity_strategy": "Participation ID plus independent assertion or event ID for refusal-withdrawal-scope-intervention-discontinuation-and-reason; subject name, study name, date, state, pseudonym and arm never identify a record alone.", "source_refs": [ "SRC-001", "SRC-003", "SRC-004", "SRC-006", "SRC-008", "SRC-010", "SRC-016" ] } ], "inline_only_rationale": null }, { "id": "lost-to-followup-completion-off-study-death-reference-and-outcome", "name": "Lost to follow-up, completion, off-study, death reference and outcome", "description": "Records lost to follow-up, completion, off-study, death reference and outcome as source-qualified participation context while keeping person, study, protocol, consent artifact, intervention, observation, safety, payment and identity-linkage masters external.", "source_refs": [ "SRC-001", "SRC-003", "SRC-004", "SRC-006", "SRC-008", "SRC-010", "SRC-016" ], "questions": [ { "id": "lost-to-followup-completion-off-study-death-reference-and-outcome-q01", "text": "What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish lost to follow-up, completion, off-study, death reference and outcome?", "kind": "state", "answer_data": [ "identifiers, class and participation scope", "source-qualified values and versions", "unknown and not-applicable states" ] }, { "id": "lost-to-followup-completion-off-study-death-reference-and-outcome-q02", "text": "Who may assert, review, correct or rely on lost to follow-up, completion, off-study, death reference and outcome, under which authority, purpose and limits?", "kind": "relationship", "answer_data": [ "participant, representative and research roles", "authority, policy, purpose and limits", "review, exception and escalation path" ] }, { "id": "lost-to-followup-completion-off-study-death-reference-and-outcome-q03", "text": "Which event, effective, recorded, ingested and knowledge times apply to lost to follow-up, completion, off-study, death reference and outcome, and which evidence supports them?", "kind": "ownership", "answer_data": [ "distinct event and knowledge times", "evidence, provenance and uncertainty", "successor correction and retention" ] } ], "data_elements": [ { "id": "lost-to-followup-completion-off-study-death-reference-and-outcome-data", "name": "Lost to follow-up, completion, off-study, death reference and outcome data", "description": "Typed data for lost to follow-up, completion, off-study, death reference and outcome with identity, study scope, source, authority, state, time, evidence and provenance.", "value_kind": "collection", "cardinality": "0..n", "required": false, "source_refs": [ "SRC-001", "SRC-003", "SRC-004", "SRC-006", "SRC-008", "SRC-010", "SRC-016" ] } ], "artifacts": [ { "id": "lost-to-followup-completion-off-study-death-reference-and-outcome-record", "name": "Lost to follow-up, completion, off-study, death reference and outcome record", "description": "Immutable or successor-versioned participation evidence for lost to follow-up, completion, off-study, death reference and outcome.", "media_or_form": [ "logical research-participation assertion", "identity, permission, state, activity, safety, outcome, privacy or projection record" ], "serial": true, "identity_strategy": "Participation ID plus independent assertion or event ID for lost-to-followup-completion-off-study-death-reference-and-outcome; subject name, study name, date, state, pseudonym and arm never identify a record alone.", "source_refs": [ "SRC-001", "SRC-003", "SRC-004", "SRC-006", "SRC-008", "SRC-010", "SRC-016" ] } ], "inline_only_rationale": null } ] } ] }, { "id": "privacy-deidentification-correction-retention-and-interoperability", "name": "Privacy, de-identification, correction, retention and interoperability", "description": "Groups governed participation context for privacy, de-identification, correction, retention and interoperability.", "rationale": "Protected use requires purpose-bound views, successor corrections and version-pinned projections.", "source_refs": [ "SRC-001", "SRC-003", "SRC-004", "SRC-006", "SRC-007", "SRC-008", "SRC-009", "SRC-010", "SRC-011", "SRC-012", "SRC-013", "SRC-014", "SRC-015", "SRC-016", "SRC-017", "SRC-018" ], "layers": [ { "id": "data-specimen-use-privacy-and-linkage", "name": "Data or specimen use, privacy and linkage", "description": "Groups source-qualified participation context for data or specimen use, privacy and linkage.", "source_refs": [ "SRC-001", "SRC-003", "SRC-004", "SRC-010", "SRC-014", "SRC-016" ], "findings": [ { "id": "data-specimen-future-contact-secondary-use-withdrawal-and-retention-scope", "name": "Data, specimen, future contact, secondary use, withdrawal and retention scope", "description": "Records data, specimen, future contact, secondary use, withdrawal and retention scope as source-qualified participation context while keeping person, study, protocol, consent artifact, intervention, observation, safety, payment and identity-linkage masters external.", "source_refs": [ "SRC-001", "SRC-003", "SRC-004", "SRC-010", "SRC-014", "SRC-016" ], "questions": [ { "id": "data-specimen-future-contact-secondary-use-withdrawal-and-retention-scope-q01", "text": "What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish data, specimen, future contact, secondary use, withdrawal and retention scope?", "kind": "privacy", "answer_data": [ "identifiers, class and participation scope", "source-qualified values and versions", "unknown and not-applicable states" ] }, { "id": "data-specimen-future-contact-secondary-use-withdrawal-and-retention-scope-q02", "text": "Who may assert, review, correct or rely on data, specimen, future contact, secondary use, withdrawal and retention scope, under which authority, purpose and limits?", "kind": "authority", "answer_data": [ "participant, representative and research roles", "authority, policy, purpose and limits", "review, exception and escalation path" ] }, { "id": "data-specimen-future-contact-secondary-use-withdrawal-and-retention-scope-q03", "text": "Which event, effective, recorded, ingested and knowledge times apply to data, specimen, future contact, secondary use, withdrawal and retention scope, and which evidence supports them?", "kind": "measurement", "answer_data": [ "distinct event and knowledge times", "evidence, provenance and uncertainty", "successor correction and retention" ] } ], "data_elements": [ { "id": "data-specimen-future-contact-secondary-use-withdrawal-and-retention-scope-data", "name": "Data, specimen, future contact, secondary use, withdrawal and retention scope data", "description": "Typed data for data, specimen, future contact, secondary use, withdrawal and retention scope with identity, study scope, source, authority, state, time, evidence and provenance.", "value_kind": "collection", "cardinality": "1", "required": true, "source_refs": [ "SRC-001", "SRC-003", "SRC-004", "SRC-010", "SRC-014", "SRC-016" ] } ], "artifacts": [ { "id": "data-specimen-future-contact-secondary-use-withdrawal-and-retention-scope-record", "name": "Data, specimen, future contact, secondary use, withdrawal and retention scope record", "description": "Immutable or successor-versioned participation evidence for data, specimen, future contact, secondary use, withdrawal and retention scope.", "media_or_form": [ "logical research-participation assertion", "identity, permission, state, activity, safety, outcome, privacy or projection record" ], "serial": true, "identity_strategy": "Participation ID plus independent assertion or event ID for data-specimen-future-contact-secondary-use-withdrawal-and-retention-scope; subject name, study name, date, state, pseudonym and arm never identify a record alone.", "source_refs": [ "SRC-001", "SRC-003", "SRC-004", "SRC-010", "SRC-014", "SRC-016" ] } ], "inline_only_rationale": null }, { "id": "pseudonymization-deidentification-linkage-reidentification-risk-and-authority", "name": "Pseudonymization, de-identification, linkage, re-identification risk and authority", "description": "Records pseudonymization, de-identification, linkage, re-identification risk and authority as source-qualified participation context while keeping person, study, protocol, consent artifact, intervention, observation, safety, payment and identity-linkage masters external.", "source_refs": [ "SRC-001", "SRC-003", "SRC-004", "SRC-010", "SRC-014", "SRC-016" ], "questions": [ { "id": "pseudonymization-deidentification-linkage-reidentification-risk-and-authority-q01", "text": "What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish pseudonymization, de-identification, linkage, re-identification risk and authority?", "kind": "security", "answer_data": [ "identifiers, class and participation scope", "source-qualified values and versions", "unknown and not-applicable states" ] }, { "id": "pseudonymization-deidentification-linkage-reidentification-risk-and-authority-q02", "text": "Who may assert, review, correct or rely on pseudonymization, de-identification, linkage, re-identification risk and authority, under which authority, purpose and limits?", "kind": "requirement", "answer_data": [ "participant, representative and research roles", "authority, policy, purpose and limits", "review, exception and escalation path" ] }, { "id": "pseudonymization-deidentification-linkage-reidentification-risk-and-authority-q03", "text": "Which event, effective, recorded, ingested and knowledge times apply to pseudonymization, de-identification, linkage, re-identification risk and authority, and which evidence supports them?", "kind": "exception", "answer_data": [ "distinct event and knowledge times", "evidence, provenance and uncertainty", "successor correction and retention" ] } ], "data_elements": [ { "id": "pseudonymization-deidentification-linkage-reidentification-risk-and-authority-data", "name": "Pseudonymization, de-identification, linkage, re-identification risk and authority data", "description": "Typed data for pseudonymization, de-identification, linkage, re-identification risk and authority with identity, study scope, source, authority, state, time, evidence and provenance.", "value_kind": "collection", "cardinality": "1", "required": true, "source_refs": [ "SRC-001", "SRC-003", "SRC-004", "SRC-010", "SRC-014", "SRC-016" ] } ], "artifacts": [ { "id": "pseudonymization-deidentification-linkage-reidentification-risk-and-authority-record", "name": "Pseudonymization, de-identification, linkage, re-identification risk and authority record", "description": "Immutable or successor-versioned participation evidence for pseudonymization, de-identification, linkage, re-identification risk and authority.", "media_or_form": [ "logical research-participation assertion", "identity, permission, state, activity, safety, outcome, privacy or projection record" ], "serial": true, "identity_strategy": "Participation ID plus independent assertion or event ID for pseudonymization-deidentification-linkage-reidentification-risk-and-authority; subject name, study name, date, state, pseudonym and arm never identify a record alone.", "source_refs": [ "SRC-001", "SRC-003", "SRC-004", "SRC-010", "SRC-014", "SRC-016" ] } ], "inline_only_rationale": null } ] }, { "id": "access-correction-retention-and-projections", "name": "Access, correction, retention and projections", "description": "Groups source-qualified participation context for access, correction, retention and projections.", "source_refs": [ "SRC-001", "SRC-004", "SRC-006", "SRC-007", "SRC-008", "SRC-009", "SRC-010", "SRC-011", "SRC-012", "SRC-013", "SRC-015", "SRC-016", "SRC-017", "SRC-018" ], "findings": [ { "id": "role-purpose-access-disclosure-audit-correction-hold-and-disposition", "name": "Role, purpose, access, disclosure, audit, correction, hold and disposition", "description": "Records role, purpose, access, disclosure, audit, correction, hold and disposition as source-qualified participation context while keeping person, study, protocol, consent artifact, intervention, observation, safety, payment and identity-linkage masters external.", "source_refs": [ "SRC-001", "SRC-004", "SRC-006", "SRC-007", "SRC-008", "SRC-009", "SRC-010", "SRC-011", "SRC-012", "SRC-013", "SRC-015", "SRC-016", "SRC-017", "SRC-018" ], "questions": [ { "id": "role-purpose-access-disclosure-audit-correction-hold-and-disposition-q01", "text": "What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish role, purpose, access, disclosure, audit, correction, hold and disposition?", "kind": "access", "answer_data": [ "identifiers, class and participation scope", "source-qualified values and versions", "unknown and not-applicable states" ] }, { "id": "role-purpose-access-disclosure-audit-correction-hold-and-disposition-q02", "text": "Who may assert, review, correct or rely on role, purpose, access, disclosure, audit, correction, hold and disposition, under which authority, purpose and limits?", "kind": "constraint", "answer_data": [ "participant, representative and research roles", "authority, policy, purpose and limits", "review, exception and escalation path" ] }, { "id": "role-purpose-access-disclosure-audit-correction-hold-and-disposition-q03", "text": "Which event, effective, recorded, ingested and knowledge times apply to role, purpose, access, disclosure, audit, correction, hold and disposition, and which evidence supports them?", "kind": "provenance", "answer_data": [ "distinct event and knowledge times", "evidence, provenance and uncertainty", "successor correction and retention" ] } ], "data_elements": [ { "id": "role-purpose-access-disclosure-audit-correction-hold-and-disposition-data", "name": "Role, purpose, access, disclosure, audit, correction, hold and disposition data", "description": "Typed data for role, purpose, access, disclosure, audit, correction, hold and disposition with identity, study scope, source, authority, state, time, evidence and provenance.", "value_kind": "collection", "cardinality": "1", "required": true, "source_refs": [ "SRC-001", "SRC-004", "SRC-006", "SRC-007", "SRC-008", "SRC-009", "SRC-010", "SRC-011", "SRC-012", "SRC-013", "SRC-015", "SRC-016", "SRC-017", "SRC-018" ] } ], "artifacts": [ { "id": "role-purpose-access-disclosure-audit-correction-hold-and-disposition-record", "name": "Role, purpose, access, disclosure, audit, correction, hold and disposition record", "description": "Immutable or successor-versioned participation evidence for role, purpose, access, disclosure, audit, correction, hold and disposition.", "media_or_form": [ "logical research-participation assertion", "identity, permission, state, activity, safety, outcome, privacy or projection record" ], "serial": true, "identity_strategy": "Participation ID plus independent assertion or event ID for role-purpose-access-disclosure-audit-correction-hold-and-disposition; subject name, study name, date, state, pseudonym and arm never identify a record alone.", "source_refs": [ "SRC-001", "SRC-004", "SRC-006", "SRC-007", "SRC-008", "SRC-009", "SRC-010", "SRC-011", "SRC-012", "SRC-013", "SRC-015", "SRC-016", "SRC-017", "SRC-018" ] } ], "inline_only_rationale": null }, { "id": "fhir-cdisc-who-clinicaltrials-registry-projection-version-and-loss", "name": "FHIR, CDISC, WHO, ClinicalTrials registry projection, version and loss", "description": "Records fhir, cdisc, who, clinicaltrials registry projection, version and loss as source-qualified participation context while keeping person, study, protocol, consent artifact, intervention, observation, safety, payment and identity-linkage masters external.", "source_refs": [ "SRC-001", "SRC-004", "SRC-006", "SRC-007", "SRC-008", "SRC-009", "SRC-010", "SRC-011", "SRC-012", "SRC-013", "SRC-015", "SRC-016", "SRC-017", "SRC-018" ], "questions": [ { "id": "fhir-cdisc-who-clinicaltrials-registry-projection-version-and-loss-q01", "text": "What stable identity, subject-to-study scope, source-qualified values and explicit unknowns establish fhir, cdisc, who, clinicaltrials registry projection, version and loss?", "kind": "interoperability", "answer_data": [ "identifiers, class and participation scope", "source-qualified values and versions", "unknown and not-applicable states" ] }, { "id": "fhir-cdisc-who-clinicaltrials-registry-projection-version-and-loss-q02", "text": "Who may assert, review, correct or rely on fhir, cdisc, who, clinicaltrials registry projection, version and loss, under which authority, purpose and limits?", "kind": "event", "answer_data": [ "participant, representative and research roles", "authority, policy, purpose and limits", "review, exception and escalation path" ] }, { "id": "fhir-cdisc-who-clinicaltrials-registry-projection-version-and-loss-q03", "text": "Which event, effective, recorded, ingested and knowledge times apply to fhir, cdisc, who, clinicaltrials registry projection, version and loss, and which evidence supports them?", "kind": "process", "answer_data": [ "distinct event and knowledge times", "evidence, provenance and uncertainty", "successor correction and retention" ] } ], "data_elements": [ { "id": "fhir-cdisc-who-clinicaltrials-registry-projection-version-and-loss-data", "name": "FHIR, CDISC, WHO, ClinicalTrials registry projection, version and loss data", "description": "Typed data for fhir, cdisc, who, clinicaltrials registry projection, version and loss with identity, study scope, source, authority, state, time, evidence and provenance.", "value_kind": "collection", "cardinality": "0..n", "required": false, "source_refs": [ "SRC-001", "SRC-004", "SRC-006", "SRC-007", "SRC-008", "SRC-009", "SRC-010", "SRC-011", "SRC-012", "SRC-013", "SRC-015", "SRC-016", "SRC-017", "SRC-018" ] } ], "artifacts": [ { "id": "fhir-cdisc-who-clinicaltrials-registry-projection-version-and-loss-record", "name": "FHIR, CDISC, WHO, ClinicalTrials registry projection, version and loss record", "description": "Immutable or successor-versioned participation evidence for fhir, cdisc, who, clinicaltrials registry projection, version and loss.", "media_or_form": [ "logical research-participation assertion", "identity, permission, state, activity, safety, outcome, privacy or projection record" ], "serial": true, "identity_strategy": "Participation ID plus independent assertion or event ID for fhir-cdisc-who-clinicaltrials-registry-projection-version-and-loss; subject name, study name, date, state, pseudonym and arm never identify a record alone.", "source_refs": [ "SRC-001", "SRC-004", "SRC-006", "SRC-007", "SRC-008", "SRC-009", "SRC-010", "SRC-011", "SRC-012", "SRC-013", "SRC-015", "SRC-016", "SRC-017", "SRC-018" ] } ], "inline_only_rationale": null } ] } ] } ] }, "functions": [ { "id": "register-participation", "name": "Register research participation", "description": "Governed operation to register research participation without autonomous recruitment, consent, clinical decision, intervention, disclosure, re-identification or deletion.", "inputs": [ "subject master reference", "study reference", "subject profile", "authority" ], "outputs": [ "stable participation aggregate" ], "preconditions": [ "study, subject, protocol, site and jurisdiction are resolved", "creation is authorized" ], "effects": [ "a new subject-to-study participation head is created without copying external masters" ], "source_refs": [ "SRC-001", "SRC-004", "SRC-008", "SRC-015" ] }, { "id": "bind-identifiers-and-profile", "name": "Bind identifiers and subject profile", "description": "Governed operation to bind identifiers and subject profile without autonomous recruitment, consent, clinical decision, intervention, disclosure, re-identification or deletion.", "inputs": [ "participation", "identifier assertions", "subject profile" ], "outputs": [ "scoped identifier bindings" ], "preconditions": [ "issuer, namespace, purpose, sensitivity and validity are known" ], "effects": [ "public, operational, pseudonymous and restricted identifiers remain distinguishable" ], "source_refs": [ "SRC-004", "SRC-008", "SRC-014", "SRC-016" ] }, { "id": "record-recruitment-and-screening", "name": "Record recruitment and screening", "description": "Governed operation to record recruitment and screening without autonomous recruitment, consent, clinical decision, intervention, disclosure, re-identification or deletion.", "inputs": [ "participation", "contact authority", "screening events" ], "outputs": [ "recruitment and screening history" ], "preconditions": [ "approved procedures, source, actor and times are present" ], "effects": [ "candidate and screening evidence is appended without implying consent or enrolment" ], "source_refs": [ "SRC-001", "SRC-003", "SRC-004", "SRC-006" ] }, { "id": "record-eligibility-decision", "name": "Record eligibility decision", "description": "Governed operation to record eligibility decision without autonomous recruitment, consent, clinical decision, intervention, disclosure, re-identification or deletion.", "inputs": [ "criteria version", "evaluations", "authorized decision" ], "outputs": [ "source-qualified eligibility decision" ], "preconditions": [ "criteria, evaluator, evidence, waivers and jurisdiction pass" ], "effects": [ "eligibility is recorded without autonomous clinical or enrolment action" ], "source_refs": [ "SRC-001", "SRC-004", "SRC-006", "SRC-007" ] }, { "id": "bind-consent-assent-and-permission", "name": "Bind consent, assent and permission", "description": "Governed operation to bind consent, assent and permission without autonomous recruitment, consent, clinical decision, intervention, disclosure, re-identification or deletion.", "inputs": [ "participation", "source consent artifacts", "grantor and representative authority" ], "outputs": [ "scoped permission bindings" ], "preconditions": [ "version, process, actor, capacity, scope, period and verification pass" ], "effects": [ "permission state is linked without replacing source artifacts or enforcement" ], "source_refs": [ "SRC-001", "SRC-003", "SRC-004", "SRC-010" ] }, { "id": "enroll-allocate-and-blind", "name": "Record enrolment, allocation and blinding", "description": "Governed operation to record enrolment, allocation and blinding without autonomous recruitment, consent, clinical decision, intervention, disclosure, re-identification or deletion.", "inputs": [ "eligible and permitted participation", "allocation event", "blinding policy" ], "outputs": [ "enrolment and assignment events" ], "preconditions": [ "prerequisites, authority, method, concealment and views pass" ], "effects": [ "planned assignment is recorded separately from actual exposure" ], "source_refs": [ "SRC-001", "SRC-004", "SRC-006", "SRC-008" ] }, { "id": "record-participation-activities", "name": "Record participation activities", "description": "Governed operation to record participation activities without autonomous recruitment, consent, clinical decision, intervention, disclosure, re-identification or deletion.", "inputs": [ "participation", "planned activities", "actual event references" ], "outputs": [ "actual participation history" ], "preconditions": [ "activity, visit, exposure, observation, actor, source and time pass" ], "effects": [ "actual events, adherence and deviations are appended without rewriting plans" ], "source_refs": [ "SRC-001", "SRC-002", "SRC-008", "SRC-011", "SRC-012" ] }, { "id": "record-safety-and-compensation-links", "name": "Record safety and compensation links", "description": "Governed operation to record safety and compensation links without autonomous recruitment, consent, clinical decision, intervention, disclosure, re-identification or deletion.", "inputs": [ "participation", "safety, care, injury or payment references" ], "outputs": [ "typed protected links" ], "preconditions": [ "urgency, authority, privacy, causality source and reporting status pass" ], "effects": [ "external safety, medical and payment masters remain authoritative" ], "source_refs": [ "SRC-001", "SRC-003", "SRC-004", "SRC-006", "SRC-013" ] }, { "id": "withdraw-discontinue-followup-or-close", "name": "Withdraw, discontinue, follow up or close", "description": "Governed operation to withdraw, discontinue, follow up or close without autonomous recruitment, consent, clinical decision, intervention, disclosure, re-identification or deletion.", "inputs": [ "participation", "scope", "reason", "authorized event" ], "outputs": [ "successor status and disposition" ], "preconditions": [ "intervention, participation, contact, data and specimen scopes are explicit" ], "effects": [ "exit semantics and post-exit duties remain distinct and auditable" ], "source_refs": [ "SRC-001", "SRC-003", "SRC-004", "SRC-006", "SRC-010" ] }, { "id": "correct-project-retain-disclose-and-audit", "name": "Correct, project, retain, disclose and audit", "description": "Governed operation to correct, project, retain, disclose and audit without autonomous recruitment, consent, clinical decision, intervention, disclosure, re-identification or deletion.", "inputs": [ "participation", "target profile", "access and records policy" ], "outputs": [ "successor, projection, disclosure, tombstone or disposition event" ], "preconditions": [ "mapping versions, loss, privacy, hold, authority and idempotency pass" ], "effects": [ "protected context stays reconstructable and explicit about current head and loss" ], "source_refs": [ "SRC-001", "SRC-007", "SRC-008", "SRC-010", "SRC-011", "SRC-012", "SRC-014", "SRC-015", "SRC-016", "SRC-017", "SRC-018" ] } ], "composition": [ { "target": "WM-ACT-036 Research Study", "relation": "REFERENCE", "purpose": "Bind candidate parent study membership without owning study governance, protocol or results.", "required": true, "source_refs": [ "SRC-001", "SRC-002", "SRC-008", "SRC-009" ] }, { "target": "Person, animal, organization, specimen, device or product subject model", "relation": "REFERENCE", "purpose": "Resolve who or what participates while preserving the external subject lifecycle.", "required": true, "source_refs": [ "SRC-004", "SRC-005", "SRC-008" ] }, { "target": "Protocol, ethics, consent, criterion, intervention, observation, adverse-event, care, payment, identity-linkage, provenance, audit and records models", "relation": "REFERENCE", "purpose": "Resolve authoritative research and evidence records without absorbing their ownership or lifecycle.", "required": false, "source_refs": [ "SRC-001", "SRC-003", "SRC-004", "SRC-006", "SRC-010", "SRC-015", "SRC-016" ] }, { "target": "FHIR R5, CDISC ODM 2.0, CDASHIG 2.2, WHO TRDS 1.3.1 and ClinicalTrials.gov", "relation": "ALIGN", "purpose": "Project version-pinned clinical and registry views with maturity, scope and information-loss declarations.", "required": false, "source_refs": [ "SRC-007", "SRC-008", "SRC-009", "SRC-010", "SRC-011", "SRC-012", "SRC-018" ] } ], "serviceLayers": { "dimension": { "owner_package_requirements": [ "Dimension owner and research-processing mandate", "Authoritative subject, study, protocol, site, ethics, consent, intervention, observation, safety, payment, identity-linkage, provenance, audit and record registries", "Approved research-type, jurisdiction, recruitment, eligibility, consent, allocation, safety, privacy, retention and interoperability profiles", "Role, delegation, emergency, unblinding, re-identification, disclosure and agent-operation policies" ], "namespace_guidance": "Mint participation, identifier-binding, screening, decision, permission, enrolment, allocation, state, activity, deviation, safety-link, withdrawal, correction, disclosure and event IDs; preserve external master identifiers.", "registry_links": [ "https://ver.cy/models/", "https://ver.cy/model-agent-protocol.md" ] }, "canon_and_patch": { "canonicalization_rules": [ "Canonicalize one participation by authoritative research-system identifier, subject reference, study reference and owning namespace; never by name, pseudonym, arm, state or date alone.", "Keep person or other subject, research study, participation, consent artifact, eligibility decision, allocation event, intervention, observation, adverse event and payment independently identifiable." ], "patch_rules": [ "Extensions declare research type, subject kind, jurisdiction, ethics, privacy, retention and interoperability effects.", "Released identity, permission, allocation, state, activity, safety, withdrawal and disclosure assertions are immutable; corrections create linked successors.", "Never silently change subject or study binding, consent scope, eligibility, assignment, exposure, safety, withdrawal, privacy, retention or provenance." ], "compatibility_rules": [ "Ignore additive fields only when participation identity, subject and study scope, record kind, source, authority, state, time, privacy and provenance survive.", "Every projection pins standard, implementation guide, profile, code-list and mapping versions and declares information loss." ] }, "artifact_rules": { "identity_priority": [ "Authoritative master-system identifier for each participation, assertion, decision, permission or event, qualified by issuer, namespace and record kind.", "Governed globally resolvable research-participation IRI.", "Dimension UUID or ULID when neither preceding identifier exists." ], "timestamp_rule": "Use RFC 3339 timestamps with seconds and explicit offset or Z; distinguish recruitment, screening, decision, consent, enrolment, allocation, activity, observation, safety, withdrawal, recorded, ingested and knowledge times whenever they differ.", "serial_naming_rule": "Use {participation-id}--{assertion-or-event-id}--{artifact-kind}--{revision-id}.", "integrity_rule": "Store digest, media type, record kind, study and subject scope, protocol and profile versions, actor, event and knowledge times, privacy marking and provenance." }, "policies": [ "The aggregate does not own Person, Animal, Organization, Specimen, Device, Study, Protocol, Consent Artifact, Eligibility Criterion, Intervention, Observation, Adverse Event, Payment, Identity Linkage, Ethics Decision, Provenance, Access Audit or Record masters.", "Recruitment, screening, eligibility, consent, enrolment, allocation, participation, exposure, adherence, safety, withdrawal and completion are independently sourced states or events.", "Pseudonymization and de-identification do not prove anonymity or eliminate re-identification risk.", "Agents cannot recruit, decide eligibility, obtain consent, enroll, allocate, intervene, unblind, re-identify, make safety decisions, compensate, disclose or delete outside explicit delegated authority." ], "crud": { "read": [ "Resolve purpose, current head, subject and study binding, identifiers, recruitment, screening, eligibility, permission, enrolment, allocation, activities, safety, state, withdrawal, privacy, retention, evidence and projection loss under the permitted view." ], "create": [ "Bind stable participation identity, external subject and study references, profile, owner, jurisdiction, source, authority, initial state and event time before adding participation context." ], "update": [ "Append successor decision, permission, state, activity, safety, withdrawal, correction and disclosure events with reason, authority, expected revision, event time and knowledge time." ], "delete": [ "Apply consent, research, privacy, legal-hold and adopting-Dimension retention policy; retire or tombstone only the participation assertion without cascading to subject, study or evidence masters, and let the external records policy execute physical disposition." ] }, "roles": [ { "name": "Research participant or authorized representative", "responsibilities": [ "Exercise applicable information, permission, refusal, withdrawal and rights processes without being treated as the data owner by default." ] }, { "name": "Principal investigator and site investigator", "responsibilities": [ "Own qualified subject protection, clinical oversight, protocol conduct and source-qualified decisions within delegation." ] }, { "name": "Sponsor and research owner", "responsibilities": [ "Own study purpose, quality system, oversight, risk management and accountable trial responsibilities." ] }, { "name": "IRB or independent ethics committee", "responsibilities": [ "Provide independent ethical review and continuing oversight according to applicable rules." ] }, { "name": "Research coordinator and delegated staff", "responsibilities": [ "Perform documented recruitment, screening, consent support, visits and data capture within delegated scope." ] }, { "name": "Safety and medical monitor", "responsibilities": [ "Review safety evidence and perform authorized reporting and medical escalation without autonomous agent substitution." ] }, { "name": "Privacy, data and records steward", "responsibilities": [ "Own protected views, linkage controls, data use, disclosures, corrections, holds, retention and auditability." ] } ], "access": { "default_rule": "Deny participant identity, linkage, consent, eligibility, allocation, safety, health, payment and contact data unless a purpose-bound policy permits the minimum necessary view.", "scopes": [ "bundle", "layer", "finding", "artifact" ], "exceptions": [ "Declared care, safety, monitoring, audit, inspection, subject-rights, legal or emergency access must cite authority, scope, purpose and time limit where applicable and must be logged." ], "audit_requirements": [ "Log actor, agent, role, purpose, participation, subject and study scope, operation, authority, policy, RFC 3339 time, affected fields, source revision and outcome without unnecessary identity duplication." ] }, "agents_bootstrap": { "filename": "AGENTS.md", "required_fields": [ "Name", "Type", "Specification URL", "Storage type URL", "Interface URL", "Processes URL" ], "read_order": [ "Read Dimension research, ethics, consent, identity, safety, privacy, access, correction, retention and agent policies.", "Read this aggregate and linked subject, study, protocol, consent, intervention, observation, safety, payment, provenance and records models before mutation." ] } }, "coverage": { "claim": "WM-ACT-054 covers one source-qualified research subject-to-study participation aggregate from candidate identification through screening, permission, enrolment, allocation, actual participation, safety, exit, protected data and specimen use, correction, retention and projection. Candidate containment, research-type and jurisdiction profiles, ethics and privacy review, release-pinned mappings and independent external review remain deferred.", "confidence": "medium", "checklist": [ { "dimension": "identity", "status": "covered", "notes": "Identity is explicit; candidate containment, research-type and jurisdiction profiles, ethics and privacy review, release-pinned mappings and independent review remain held where applicable." }, { "dimension": "classification and direct properties", "status": "covered", "notes": "Classification and direct properties is explicit; candidate containment, research-type and jurisdiction profiles, ethics and privacy review, release-pinned mappings and independent review remain held where applicable." }, { "dimension": "recognition and observation", "status": "covered", "notes": "Recognition and observation is explicit; candidate containment, research-type and jurisdiction profiles, ethics and privacy review, release-pinned mappings and independent review remain held where applicable." }, { "dimension": "capabilities and possible actions", "status": "covered", "notes": "Capabilities and possible actions is explicit; candidate containment, research-type and jurisdiction profiles, ethics and privacy review, release-pinned mappings and independent review remain held where applicable." }, { "dimension": "composition", "status": "covered", "notes": "Composition is explicit; candidate containment, research-type and jurisdiction profiles, ethics and privacy review, release-pinned mappings and independent review remain held where applicable." }, { "dimension": "lifecycle", "status": "covered", "notes": "Lifecycle is explicit; candidate containment, research-type and jurisdiction profiles, ethics and privacy review, release-pinned mappings and independent review remain held where applicable." }, { "dimension": "relationships", "status": "covered", "notes": "Relationships is explicit; candidate containment, research-type and jurisdiction profiles, ethics and privacy review, release-pinned mappings and independent review remain held where applicable." }, { "dimension": "temporal", "status": "covered", "notes": "Temporal is explicit; candidate containment, research-type and jurisdiction profiles, ethics and privacy review, release-pinned mappings and independent review remain held where applicable." }, { "dimension": "spatial", "status": "covered", "notes": "Spatial is explicit; candidate containment, research-type and jurisdiction profiles, ethics and privacy review, release-pinned mappings and independent review remain held where applicable." }, { "dimension": "provenance", "status": "covered", "notes": "Provenance is explicit; candidate containment, research-type and jurisdiction profiles, ethics and privacy review, release-pinned mappings and independent review remain held where applicable." }, { "dimension": "ownership and stewardship", "status": "covered", "notes": "Ownership and stewardship is explicit; candidate containment, research-type and jurisdiction profiles, ethics and privacy review, release-pinned mappings and independent review remain held where applicable." }, { "dimension": "validation and quality", "status": "covered", "notes": "Validation and quality is explicit; candidate containment, research-type and jurisdiction profiles, ethics and privacy review, release-pinned mappings and independent review remain held where applicable." }, { "dimension": "access and privacy", "status": "covered", "notes": "Access and privacy is explicit; candidate containment, research-type and jurisdiction profiles, ethics and privacy review, release-pinned mappings and independent review remain held where applicable." }, { "dimension": "retention and deletion", "status": "covered", "notes": "Retention and deletion is explicit; candidate containment, research-type and jurisdiction profiles, ethics and privacy review, release-pinned mappings and independent review remain held where applicable." }, { "dimension": "interoperability", "status": "covered", "notes": "Interoperability is explicit; candidate containment, research-type and jurisdiction profiles, ethics and privacy review, release-pinned mappings and independent review remain held where applicable." }, { "dimension": "authority and ethics", "status": "covered", "notes": "Authority and ethics is explicit; candidate containment, research-type and jurisdiction profiles, ethics and privacy review, release-pinned mappings and independent review remain held where applicable." } ], "known_omissions": [ "Claude and Grok each timed out on one bounded attempt; no independent external result was admitted.", "The only relation-ledger edge is candidate incoming WM-ACT-036 CONTAINS WM-ACT-054; it is not approved composition or cascade authority.", "Human clinical, observational, behavioral, public-health, device, animal, specimen, product, group and other research require explicit profiles.", "The ISO 14155:2026 normative text and detailed CDISC files are access-restricted; only official public metadata was used for their bounded claims." ], "conflicts": [ "Participant, human subject, animal subject, specimen, product, device, household, cluster and organization are not interchangeable subject profiles.", "Recruitment, screening, eligibility, consent, enrolment, allocation and participation are distinct events or decisions.", "Assigned arm, actual exposure and adherence remain distinct; withdrawal from intervention, participation, future contact, future data use and specimen use are not equivalent." ], "regional_assumptions": [ "Research authorization, consent, representative authority, privacy, safety reporting, compensation, retention and subject rights depend on jurisdiction, research type, institution and protocol.", "45 CFR 46 and HIPAA are United States profiles; Regulation 536/2014 and GDPR are European Union profiles; ICH, WMA and ISO adoption still requires local validation.", "FHIR R5 ResearchSubject is Trial Use, and CDISC, WHO and ClinicalTrials.gov mappings require release-pinned profiles and scope limits." ], "adversarial_checks": [ "Reject participation without stable identity, external subject and study references, profile, owner, source, authority, state, event time and current head.", "Reject enrolment inferred from screening, eligibility or consent alone, and reject actual exposure inferred from assignment.", "Reject autonomous recruitment, eligibility, consent, allocation, unblinding, re-identification, safety, compensation, disclosure or deletion.", "Reject withdrawal handling that automatically deletes or retains all data and specimens without scoped consent, protocol, law, ethics and records policy.", "Reject anonymity claims based only on pseudonymization or de-identification labels without method, context, risk, authority and evidence." ] }, "researchAdjudication": { "providerMode": "single-provider-waiver", "activeProviders": [ "codex" ], "waivedProviders": [ "claude", "grok" ], "providerPolicy": { "contract_version": "1.0.0", "mode": "single-provider-waiver", "effective_at": "2026-09-06T00:00:00Z", "scope": "Canonical single-stream subject-model research after the six-workstream consolidation", "active_providers": [ "codex" ], "waived_providers": [ { "provider": "claude", "authorized_by": "repository owner", "authorized_at": "2026-09-06T00:00:00Z", "reason": "Claude produced no result on prior 1800-second and 900-second attempts and again timed out on bounded 600-second Sonnet and 300-second Haiku passes. The owner prioritized completion over provider availability." }, { "provider": "grok", "authorized_by": "repository owner", "authorized_at": "2026-09-06T00:00:00Z", "reason": "The repository owner authorized completion without Grok when Grok is unavailable, slow or schema-invalid. Grok may still be attempted as a bounded supplemental reviewer, but its failure never blocks a valid Claude plus no-tools result." } ], "review_rule": "Codex may complete source-grounded fallback research after bounded Claude and Grok attempts fail. It requires a separate no-tools adversarial audit and remains reviewable-draft with a visible absence-of-external-review hold.", "supplemental_provider_attempts": [ { "provider": "claude", "required": false, "maximum_attempts": 1, "failure_policy": "record-and-continue", "admission_rule": "Use only a locally schema-valid result whose sources and boundaries survive adjudication." }, { "provider": "grok", "required": false, "maximum_attempts": 1, "failure_policy": "record-and-continue", "admission_rule": "Use only a locally schema-valid result whose sources and boundaries survive adjudication." } ] }, "boundaryDecision": { "entry_kind": "aggregate", "status": "accepted", "rationale": "The subject composes independently identifiable identifier bindings, screening events, eligibility decisions, permission sources, enrolment and allocation events, activities, state transitions, safety links and withdrawal assertions over one subject-to-study relationship. Aggregate is more accurate than person, study or event. The frozen record_plane world-model and catalogue entry_kind standalone-mm are separate axes." }, "decisions": [ { "concept": "Participation versus subject and study masters", "disposition": "accepted", "rationale": "The aggregate owns one study-specific participation relationship. Person or other subject and Research Study remain external masters." }, { "concept": "Subject profiles", "disposition": "accepted-with-profile-hold", "rationale": "Human, animal, specimen, product, device, group, household and organization participation have different identity, ethics and lifecycle semantics and require explicit profiles." }, { "concept": "Recruitment through enrolment", "disposition": "accepted", "rationale": "Recruitment, contact, prescreening, screening, eligibility, permission, enrolment, allocation and participation are distinct source-qualified processes, events or decisions." }, { "concept": "Consent, assent and representative permission", "disposition": "accepted-external", "rationale": "External repositories own source artifacts and validity. Participation owns scoped, versioned bindings and independently records consent, assent, representative permission, refusal, reconsent and withdrawal." }, { "concept": "Assignment versus actual participation", "disposition": "accepted", "rationale": "Planned arm, assigned group, allocation concealment, actual exposure, adherence and protocol deviation remain independent assertions." }, { "concept": "Withdrawal and post-exit data use", "disposition": "accepted", "rationale": "Withdrawal from intervention, participation, future contact, data use and specimen use have separate scopes; retention or disposition follows permission, protocol, law, ethics and records policy." }, { "concept": "Privacy and de-identification", "disposition": "accepted-with-mandatory-hold", "rationale": "Pseudonymization and de-identification do not establish anonymity. Linkage, re-identification, disclosure and direct-identifier views remain protected and purpose-bound." }, { "concept": "Candidate containment", "disposition": "deferred", "rationale": "The incoming WM-ACT-036 CONTAINS WM-ACT-054 relation remains candidate. It supports a parent study reference but grants no protocol ownership, mutation or cascade behavior." }, { "concept": "Machine-readable projections", "disposition": "accepted-with-validation-hold", "rationale": "FHIR R5, CDISC ODM and CDASH, WHO TRDS and ClinicalTrials.gov cover different scopes and maturity levels. Every mapping must pin version, profile and information loss." }, { "concept": "Single-provider waiver and no-tools audit", "disposition": "accepted-with-mandatory-hold", "rationale": "One Claude Sonnet and one Grok 4.6 research attempt each timed out after 120 seconds. Codex audited the frozen validated result and comparison locally without tools or new research facts. Confidence remains medium and assurance remains reviewable-draft." } ], "publicationHolds": [ "Absence-of-external-review hold: one Claude Sonnet and one Grok 4.6 research attempt for WM-ACT-054 each timed out after 120 seconds. No external research result was admitted.", "Relation hold: WM-ACT-036 CONTAINS WM-ACT-054 remains candidate and grants no ownership, mutation or cascade behavior.", "Research-profile hold: human clinical, observational, behavioral, public-health, device, animal, specimen, product, group and other research require explicit subject, ethics and jurisdiction profiles.", "Ethics and privacy hold: eligibility, consent, representative authority, safety, compensation, re-identification, data and specimen use, disclosure and retention require adopting-Dimension and jurisdiction policies.", "Interoperability hold: all FHIR, CDISC, WHO and ClinicalTrials.gov projections require release-pinned mappings, maturity and scope constraints, information-loss declarations and validation.", "Source-access hold: ISO 14155:2026 normative text and detailed CDISC files were not publicly inspected; claims from them are limited to official public metadata.", "Independent external review was explicitly waived by the repository owner; this codex-only result remains a reviewable draft." ], "deferredResearch": [ "Approve or reject candidate containment by WM-ACT-036 and register subject, protocol, consent, intervention, observation, safety, payment, identity-linkage, provenance and records relations.", "Create subject and research profiles for human clinical, observational, behavioral, public-health, device, animal, specimen, product, group and other study types.", "Validate jurisdiction-specific ethics, consent, representative authority, safety, compensation, privacy, re-identification, retention and subject-rights rules.", "Test release-pinned FHIR, CDISC, WHO and ClinicalTrials.gov mappings with conformance, round-trip and information-loss evidence.", "Obtain licensed source review where needed and supplemental independent external review before canonical promotion." ] }, "statistics": { "sources": 18, "bundles": 6, "layers": 12, "findings": 24, "questions": 72, "artifacts": 24, "functions": 10 } }